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17:23 EDT Immunomedics presents interim data from TROPHY-U-01 open-label Phase 2 trial - Immunomedics (IMMU) presented at the European Society for Medical Oncology Annual Congress interim data from the 100-patient cohort of cisplatin-eligible patients of the company's TROPHY-U-01 open-label Phase 2 study. In this interim report, sacituzumab govitecan produced an overall response rate of 29% in 35 patients with metastatic urothelial cancer who have relapsed or are refractory to immune checkpoint inhibitors and platinum-based chemotherapy. The 29% ORR included two confirmed complete responses, six confirmed partial responses and two additional PRs pending confirmation. At the time of data cutoff on August 5, 2019, eight of ten responders have ongoing response. Median time to onset of response was 1.5 months. For patients with liver metastases, ORR was 25%. Consistent with the company's previous observations, sacituzumab govitecan was well tolerated with a predictable safety profile. In addition, the company announced two clinical collaborations that address continuing unmet needs in breast cancer. The collaboration with Roche (RHHBY) will evaluate the safety and efficacy of the combination of atezolizumab, a programmed cell death ligand 1-blocking checkpoint inhibitor, and sacituzumab govitecan, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC. The open-label, multicenter, randomized Phase 1b/2 study will be conducted as part of MORPHEUS, Roche's novel cancer immunotherapy development platform. Patients with newly-diagnosed mTNBC will be randomized to receive the combination of atezolizumab and sacituzumab govitecan or nab-paclitaxel plus atezolizumab as standard of care. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. Roche will be responsible for conducting the randomized trial. Further, Immunomedics and the GBG Forschungs-GmbH, Neu-Isenburg, Germany, have entered into a collaboration to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response following standard neoadjuvant therapy.

17:11 EDT ImmunoGen presents full data from Phase 3 FORWARD I study - ImmunoGen announced full data and additional exploratory analyses from the Phase 3 FORWARD I study evaluating mirvetuximab soravtansine compared to chemotherapy in women with folate receptor alpha-positive, platinum-resistant ovarian cancer during an oral presentation at the European Society for Medical Oncology 2019 Congress in Barcelona, Spain. "While it is disappointing that FORWARD I did not meet the primary endpoint of progression-free survival, mirvetuximab demonstrated consistent and meaningful efficacy signals in patients with high levels of FRalpha expression and was well tolerated with a differentiated safety profile in both the ITT and FRalpha high populations," said Kathleen Moore, Associate Director of Clinical Research at the Stephenson Cancer Center at the University of Oklahoma. The FORWARD I Phase 3 trial randomized 366 patients 2:1 to receive either mirvetuximab or the physician's choice of single-agent chemotherapy. Eligibility criteria included patients with platinum-resistant ovarian cancer that expressed medium or high levels of FRalpha, who had been treated with up to three prior regimens. The primary endpoint of this study was progression-free survival, which was assessed using the Hochberg procedure in the entire study population and in the subset of patients with high FRalpha expression. The Hochberg procedure enables the simultaneous testing of two overlapping populations. Under this statistical analysis plan, if the p-value of the primary endpoint in either population is greater than 0.05, the p-value in the other population needs to be less than or equal to 0.025 to achieve statistical significance. In the entire study population, the confirmed overall response rate was higher for mirvetuximab than for chemotherapy, without a significant difference in the primary endpoint of PFS or overall survival. In the pre-specified FRalpha high subgroup: Median PFS was longer in patients who received mirvetuximab compared with chemotherapy. Given that the p-value in the entire study population exceeded 0.05, the statistical analysis plan for the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance. Confirmed ORR was higher for mirvetuximab than for chemotherapy.

17:02 EDT Abbott announces new analyses of COAPTTM Trial - Abbott announced new analyses of the landmark COAPTTM Trial that show the company's MitraClipTM device is cost effective and is projected to increase both life-expectancy and quality of life compared to guideline-directed medical therapy alone in heart failure patients with secondary mitral regurgitation (MR), or a leaky mitral heart valve. The cost-effectiveness analysis also showed additional benefits of MitraClip, including decreased use of health resources after implantation. In addition, a second late-breaking data presentation at TCT showed that over a longer-term follow-up period within the COAPT Trial, MitraClip continued to remain safe, with durable MR reduction, reduced hospitalization rates, and improved survival and quality of life compared to medical therapy alone. In tandem, the two late-breaking data sets provide strong evidence of MitraClip's impact on treating secondary MR. Significant secondary MR has historically been difficult to manage, is associated with a poor prognosis, and can lead to reduced quality of life, recurrent hospitalizations and decreased survival. The COAPT Trial cost-effectiveness analysis demonstrated: Transcatheter mitral valve repair using MitraClip in patients with significant secondary MR was projected to increase life-expectancy by 1.13 years and quality-adjusted life-years by 0.82 years. TMVr using MitraClip in patients with significant secondary MR yielded an "Incremental Cost-Effectiveness Ratio" of $55,600 per quality-adjusted life year vs GDMT. The health economic data from the COAPT Trial is the first time a pre-specified economic analysis was integrated into a pivotal randomized controlled trial that involved a mitral valve repair device. Results show that, compared with guideline directed medical therapy , TMVR using MitraClip was: Safe, provided continued reduction in MR, reduced the rate of heart failure hospitalizations; Improved survival at 36 months; Provided durable improvements in quality of life at 24 months compared to medical therapy. The three-year clinical results may further help inform a coverage review being conducted by the Centers for Medicare & Medicaid Services' for an expanded National Coverage Determination of the procedure, the company said. CMS anticipates issuing a proposed decision memo in February 2020 and will issue a final decision in May 2020.

16:55 EDT Eli Lilly presents data from LIBRETTO-001 clinical trial - Eli Lilly presented data from the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib1 monotherapy, also known as LOXO-292, for the treatment of RET-altered thyroid cancers. RET-altered thyroid cancers are comprised of two different populations, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancers. In the RET-mutant MTC registration dataset consisting of the first 55 enrolled patients with prior cabozantinib and/or vandetanib2, selpercatinib treatment resulted in a 56% objective response rate. This population was heavily pretreated, and ORR was similar regardless of prior multikinase inhibitor therapy. As of the data cut-off date of June 17, 2019, median duration of response was not reached and median progression-free survival was not reached. Selpercatinib therapy also resulted in robust biochemical response rates for serum tumor markers calcitonin and carcinoembryonic antigen. In a safety analysis of all 531 patients enrolled to LIBRETTO-001, selpercatinib was well-tolerated, with only nine patients discontinuing therapy due to treatment-related adverse events. Investigators also presented the results of selpercatinib in RET-mutant MTC patients who have received neither cabozantinib nor vandetanib. In this analysis of 76 patients, selpercatinib treatment resulted in a 59% ORR. Median DOR and PFS were not reached in this treatment-naive population, as the vast majority of patients remain in response or progression-free. Investigators also presented the results of selpercatinib in heavily pretreated RET fusion-positive thyroid cancer patients. In this analysis of 26 patients, selpercatinib treatment resulted in a 62% ORR. Median DOR and PFS were not reached in this population, as the vast majority of patients remain in response or progression-free.

16:47 EDT Calithera presents data from first-in-class oral arginase inhibitor INCB001158 - Calithera Biosciences (CALA) announced the presentation of new data from the investigational first-in-class oral arginase inhibitor INCB001158 as a monotherapy and in combination with the checkpoint inhibitor pembrolizumab in microsatellite stable colorectal carcinoma patients. Calithera has a global collaboration and license agreement with Incyte (INCY) for the joint research, development and commercialization of INCB001158 in hematology and oncology. Calithera and Incyte are collaborating to conduct this Phase 1 study evaluating INCB001158 as monotherapy and in combination with the PD-1 inhibitor pembrolizumab in checkpoint inhibitor refractory and naive advanced/metastatic solid tumors. Data were presented as of the data cut-off of July 22, 2019. The study was designed as a dose escalation of INCB001158 alone and in combination with pembrolizumab followed by expansion cohorts which followed a Simon 2 Stage design. There were three monotherapy expansion cohorts and eight combination expansion cohorts, including PD-(L)1-naive and PD-(L)1 refractory patients. The PD-(L)1-naive MSS colorectal carcinoma patient cohort has advanced to stage 2 of a Simon 2-stage design. Among 43 response-evaluable patients who had received a median of 3 prior therapies, 3 patients achieved a confirmed partial response; the historical overall response rate is 0-1% in second- and third-line MSS CRC patients treated with checkpoint inhibitor therapies. Two of the three responders are ongoing at the time of data cutoff with a duration of response of 2.4+ and 7+ months respectively. The third responder had a duration of response of 6.7 months. The six month PFS rate for the cohort was 20%. Pharmacodynamic increases in total intratumoral CD8+ cells were seen post-treatment with INCB001158 + pembrolizumab in MSS CRC patients. The colorectal carcinoma monotherapy cohort has advanced to stage 2 of a Simon 2-stage design. Among 33 response-evaluable MSS CRC patients, one patient achieved a confirmed partial response and one patient achieved stable disease lasting seven months. Both patients had disease progression within six months on their immediately preceding line of therapy. The disease control rate for the monotherapy MSS CRC cohort was 27%. INCB001158 inhibited plasma arginase activity at all doses and induced dose-related increases in plasma arginine, including a mean three-fold increase at the recommended phase 2 dose of 100 mg bid. A total of 85 patients with advanced solid tumors were treated with INCB001158 as a monotherapy in doses of 50 to 150mg bid and were evaluable for safety. A maximum tolerated dose was not reached. Immune-related adverse events included one dose-limiting toxicity each of Grade 2 malaise and Grade 3 colitis. Clinically significant urea cycle inhibition was not seen. A total of 114 PD-(L)1-naive and PD-(L)1 refractory patients were treated in INCB001158 in combination with pembrolizumab and evaluable for safety across multiple disease specific cohorts. The overall frequency and severity of immune related adverse events was consistent with the pembrolizumab safety profile.

16:44 EDT ImmunoGen says Phase 3 Forward I trial did not meet primary endpoint - ImmunoGen announced full data and additional exploratory analyses from the Phase 3 Forward I study evaluating mirvetuximab soravtansine compared to chemotherapy in women with folate receptor alpha-positive, platinum-resistant ovarian cancer during an oral presentation at the European Society for Medical Oncology 2019 Congress in Barcelona, Spain. "While it is disappointing that Forward I did not meet the primary endpoint of progression-free survival, mirvetuximab demonstrated consistent and meaningful efficacy signals in patients with high levels of FRalpha expression and was well tolerated with a differentiated safety profile in both the ITT and FRalpha high populations," said Kathleen Moore, Associate Director of Clinical Research at the Stephenson Cancer Center at the University of Oklahoma. The Forward I Phase 3 trial randomized 366 patients 2:1 to receive either mirvetuximab or the physician's choice of single-agent chemotherapy. Eligibility criteria included patients with platinum-resistant ovarian cancer that expressed medium or high levels of FRalpha, who had been treated with up to three prior regimens. The primary endpoint of this study was progression-free survival, which was assessed using the Hochberg procedure in the entire study population and in the subset of patients with high FRalpha expression. The Hochberg procedure enables the simultaneous testing of two overlapping populations. Under this statistical analysis plan, if the p-value of the primary endpoint in either population is greater than 0.05, the p-value in the other population needs to be less than or equal to 0.025 to achieve statistical significance. In the entire study population, the confirmed overall response rate was higher for mirvetuximab than for chemotherapy, without a significant difference in the primary endpoint of PFS or overall survival. In the pre-specified FRalpha high subgroup: Median PFS was longer in patients who received mirvetuximab compared with chemotherapy. Given that the p-value in the entire study population exceeded 0.05, the statistical analysis plan for the study required the p-value in the high subset to be less than or equal to 0.025 to achieve statistical significance. Confirmed ORR was higher for mirvetuximab than for chemotherapy. OS was longer in patients who received mirvetuximab compared with chemotherapy. The trend in improved OS in patients who received mirvetuximab compared with chemotherapy persisted with an additional 6 months of follow-up. Mirvetuximab was well-tolerated, with fewer patients experiencing grade 3 or greater treatment emergent adverse events, fewer dose reductions, and fewer discontinuations due to drug-related TEAEs compared with chemotherapy. The safety profile of mirvetuximab was confirmed. Over twice the percentage of patients who received mirvetuximab compared with chemotherapy reported improved quality of life, as measured by at least a 15-point improvement in the abdominal/GI symptom subscale of the EORTC-QLQ OV28.

16:37 EDT Seattle Genetics presents data from single arm Phase 2 MOUNTAINEER trial - Seattle Genetics announced that initial data were presented from the single arm phase 2 clinical trial known as MOUNTAINEER. The trial is evaluating the investigational agent tucatinib in combination with trastuzumab in patients with HER2-positive, RAS wild-type metastatic colorectal cancer after treatment with first- and second-line standard-of-care therapies. The regimen demonstrated antitumor activity and was well tolerated. Objective response rate was 52.2% with a median duration of response of 10.4 months. Median progression-free survival was 8.1 months. Median overall survival was 18.7 months. The combination of tucatinib and trastuzumab was well tolerated. The most common treatment-related adverse events were Grade 1 in severity. There were no Grade 4 or 5 treatment-related adverse events.

16:30 EDT G1 Therapeutics presents first clinical data on Oral SERD G1T48 - G1 Therapeutics announced preliminary results from a Phase 1/2a dose-escalation study of G1T48, an oral selective estrogen receptor degrader, in patients with estrogen receptor-positive, HER2-negative breast cancer. In the trial, G1T48 was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. Safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of G1T48 were evaluated in an open-label, dose-escalation Phase 1 trial. The data reported are from 26 post-menopausal women with ER+, HER2- breast cancer who were eligible to receive up to three lines of prior chemotherapy in the metastatic setting and up to three endocrine therapies, including fulvestrant, aromatase inhibitors and tamoxifen, in the metastatic setting. This was a difficult to treat, heavily pre-treated population: 65% of patients had received greater than or equal to 3 lines of therapy, 85% of patients had prior treatment with fulvestrant and most had received one or more targeted therapies. Preliminary findings showed: G1T48 was well tolerated with no dose-limiting toxicities reported at any of the five dose levels studied; maximum tolerated dose was not reached. No patient experienced a serious adverse event related to G1T48. Seven patients remain on treatment. There was a dose-dependent increase in drug exposure; dosing with food reduced variability and increased exposure. Significant decreases in 18F-FES PET uptake during G1T48 treatment indicated target engagement for all doses tested. Of 19 patients with RECIST measurable tumors: The clinical benefit rate across all doses was 15.8%. Seven patients experienced stable disease across all doses. One patient experienced a confirmed partial response. Based on safety and tolerability findings in the Phase 1b portion of this trial, the company selected the 600 mg and 1,000 mg doses of G1T48 for evaluation in the ongoing Phase 2a portion and will use these data to select the dose for pivotal trials. The company plans to initiate a first-line Phase 3 trial of G1T48 in combination with an oral CDK4/6 inhibitor for the treatment of ER+, HER2- breast cancer in 2020.

16:15 EDT Clovis announces updated data from Phase 2 TRITON2 trial - Clovis Oncology announced updated data from the Phase 2 TRITON2 trial at the European Society for Medical Oncology Congress 2019, reinforcing the potential of Rubraca for the treatment of patients with metastatic castration-resistant prostate cancer with a BRCA1/2 mutation. The data show a 43.9% confirmed objective response rate by investigator assessment in 57 RECIST/PCWG3 response-evaluable patients with a BRCA1/2 mutation. When assessed by independent radiological review, the response rate was similar. In addition, a 52.0% confirmed prostate-specific antigen response rate was observed in 98 response-evaluable patients with a BRCA1/2 mutation. Confirmed radiographic responses were durable, with 60% lasting 24 weeks or longer. The TRITON2 data will be used to support the filing of Clovis Oncology's planned supplemental NDA to the Food and Drug Administration for Rubraca in BRCA1/2-mutant advanced prostate cancer. Confirmed investigator-assessed RECIST and PSA responses were also observed in patients with alterations in other DDR genes, including ATM, CDK12, CHEK2, PALB2, BRIP1, FANCA, and RAD51B. The median duration of follow-up for patients in TRITON2 was 13.1 months with the safety profile consistent with prior reports. Clovis Oncology is further evaluating the potential of Rubraca to treat advanced prostate cancer in the TRITON3 clinical trial - a multicenter, randomized, open-label Phase 3 study of Rubraca versus physician's choice of therapy - for patients with mCRPC. TRITON3 is currently enrolling patients with BRCA1/2-mutant and ATM-mutant tumors with a primary objective of assessing radiographic progression-free survival in these patients.

16:08 EDT Abbott announces outcomes data for device to repair leaky Tricuspid heart valves - Abbott announced new data that suggest Abbott's investigational TriClip device may offer physicians an effective minimally invasive repair option for patients suffering from a leaky tricuspid valve, a condition also known as tricuspid regurgitation. For patients suffering from moderate to severe TR, the new data found treatment with TriClip was safe and associated with strong clinical improvement at six-months, including a reduction in TR and improvement in quality of life. The results build upon the initial 30 day data from the TRILUMINATE Feasibility Study, which suggested the promise of TriClip in treating people suffering from this difficult-to-manage structural heart disease. After six months, the TRILUMINATE Feasibility Study showed patients who received Abbott's TriClip device saw a number of benefits, including: Reduction of tricuspid regurgitation - Within the study, 87% of patients had a reduction in their TR at 6 months, with 57% of patients implanted having a TR classification of moderate or better vs. only 6% of patients with the same classification at the time of enrollment; Symptom improvement - Patients receiving TriClip had reduction in their symptoms, with 87% of patients implanted with TriClip being classified as NYHA functional class I/II at six months versus only 25% of patients receiving the same classification at the time of enrollment; Quality of life improvements - Patients receiving TriClip showed improved KCCQ scores and a reduction in symptoms that are associated with a reduced burden of their clinical condition and improved physical output. The TRILUMINATE Feasibility study was a prospective, single-arm, multi-center study, which investigated the performance of Abbott's proven clip-based repair technology using the tricuspid valve repair system, TriClip, in 21 sites across the U.S. and Europe.

15:58 EDT Guardant Health presents data from Phase II TRIUMPH trial - Guardant Health and the National Cancer Center Hospital East present data at the European Society of Medical Oncology conference from a prospective, multi-center phase II clinical trial, TRIUMPH. The study showed that patients with metastatic colorectal cancer with a HER2 amplification detected by the Guardant360 assay experienced clinical benefit from National Comprehensive Cancer Network guideline-recommended HER2-directed combination therapy. The study included patients with RAS-wild-type mCRC refractory to standard EGFR-directed therapies, and HER2 amplification detected using standard tissue-based testing or Guardant360. An interim analysis, led by principal investigators from the National Cancer Center Hospital East in Japan, demonstrated that mCRC patients with HER2 amplification detected by Guardant360 and treated with HER2-directed combination therapy achieved an objective response rate of 33.3%. Excluding patients with known markers of resistance detected by Guardant360, the ORR was 45.5%. The overall median progression-free survival was 4.0 months, and the median duration of response was 4.2 months. Importantly, patients with HER2-amplified tumors who also had Guardant360-detected mutations in KRAS, NRAS, PIK3CA or HER2 had much poorer responses and shorter PFS. In contrast, median PFS was 5.6 months when mutations in these genes were not detected by Guardant360.

15:46 EDT Immunomedics presents interim data from TROPHY-U-01 open-label Phase 2 trial - Immunomedics (IMMU) presented at the European Society for Medical Oncology Annual Congress interim data from the 100-patient cohort of cisplatin-eligible patients of the company's TROPHY-U-01 open-label Phase 2 study. In this interim report, sacituzumab govitecan produced an overall response rate of 29% in 35 patients with metastatic urothelial cancer who have relapsed or are refractory to immune checkpoint inhibitors and platinum-based chemotherapy. The 29% ORR included two confirmed complete responses, six confirmed partial responses and two additional PRs pending confirmation. At the time of data cutoff on August 5, 2019, eight of ten responders have ongoing response. Median time to onset of response was 1.5 months. For patients with liver metastases, ORR was 25%. Consistent with the company's previous observations, sacituzumab govitecan was well tolerated with a predictable safety profile. In addition, the company announced two clinical collaborations that address continuing unmet needs in breast cancer. The collaboration with Roche (RHHBY) will evaluate the safety and efficacy of the combination of atezolizumab, a programmed cell death ligand 1-blocking checkpoint inhibitor, and sacituzumab govitecan, as a frontline treatment of patients with metastatic or inoperable locally advanced TNBC. The open-label, multicenter, randomized Phase 1b/2 study will be conducted as part of MORPHEUS, Roche's novel cancer immunotherapy development platform. Patients with newly-diagnosed mTNBC will be randomized to receive the combination of atezolizumab and sacituzumab govitecan or nab-paclitaxel plus atezolizumab as standard of care. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. Roche will be responsible for conducting the randomized trial. Further, Immunomedics and the GBG Forschungs-GmbH, Neu-Isenburg, Germany, have entered into a collaboration to develop sacituzumab govitecan as a treatment for newly-diagnosed breast cancer patients who do not achieve a pathological complete response following standard neoadjuvant therapy.

15:31 EDT Merck, AstraZeneca announced detailed results from Phase 3 PAOLA-1 trial - AstraZeneca (AZN) and Merck (MRK) announced detailed positive results from the Phase 3 PAOLA-1 trial showing LYNPARZA added to bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in women with newly-diagnosed advanced ovarian cancer who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The trial compared LYNPARZA when added to standard-of-care (SoC) bevacizumab versus bevacizumab alone in women in the first-line maintenance setting, irrespective of their genetic biomarker status or outcome from previous surgery. Investigator-assessed results showed LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% and improved PFS to a median of 22.1 months versus 16.6 months for those treated with bevacizumab alone. The sensitivity analysis of blinded independent central review of PFS was consistent, showing a similar improvement with a median of 26.1 months for LYNPARZA added to bevacizumab versus 18.3 months for bevacizumab alone. The safety and tolerability profile of LYNPARZA and bevacizumab were consistent with those known from previous trials for each medicine. The trial also included exploratory sub-group analyses including BRCA-mutated and broader homologous recombination deficiency populations. In the BRCAm-positive sub-group, LYNPARZA added to SoC bevacizumab vs. bevacizumab alone resulted in median PFS of 37.2 months versus 21.7 months and 18.9 months versus 16 months in the non-BRCAm sub-group. For the HRD-positive sub-group, median PFS for LYNPARZA added to bevacizumab was 37.2 months versus 17.7 months with bevacizumab alone. In the HRD-positive, non-BRCAm sub-group, there was a median PFS of 28.1 months with LYNPARZA added to bevacizumab versus 16.6 months on bevacizumab alone. The HRD-negative/unknown sub-group results showed a median PFS of 16.9 months for LYNPARZA added to bevacizumab vs. 16 months for bevacizumab alone. LYNPARZA, which is being jointly developed and commercialized by Merck and AstraZeneca, is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the U.S. as first-line maintenance treatment in BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 38 countries, including the U.S., countries in the EU, and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer. LYNPARZA has been used to treat over 25,000 patients worldwide.

15:21 EDT Zymeworks announces updated data for HER2-Targeted Bispecific Antibody ZW25 - Zymeworks announced updated data from the ongoing multi-center Phase 1 clinical trial evaluating ZW25 in patients with HER2-expressing solid tumors, including biliary tract cancer, colorectal cancer, gynecological cancers, and gastroesophageal adenocarcinoma, in a poster discussion presentation at the ESMO 2019 Congress. Based on the data from the ongoing Phase 1 study, Zymeworks has initiated a broad clinical development program for ZW25 in multiple HER2-expressing cancers. In addition to the Phase 2 BTC trial announced, Zymeworks is continuing to evaluate ZW25 as a potential treatment for patients with other HER2-expressing cancers, including CRC and gynecological cancers. For patients with HER2-expressing GEA, ZW25 is being developed as a first-line treatment in combination with standard of care chemotherapy. Zymeworks also plans to initiate a Phase 2 study of ZW25 in combination with a CDK4/6 inhibitor and hormone therapy in third-line HER2-expressing, HR-positive breast cancer. Data were reported from 58 patients diagnosed with HER2-expressing solid tumors other than breast cancer who received ZW25 at the recommended dose of either 10 mg/kg weekly or 20 mg/kg every other week. Patients had a median age of 61 years and received a median of four prior therapies. 32 patients received prior HER2-targeted therapies including 87% of GEA patients. Of all patients, 23 were diagnosed with GEA, 13 with CRC, nine with BTC, and 13 with other HER2-expressing cancers, including endometrial, ovarian, pancreatic, and salivary gland. At the time of data cut-off, 46 of 58 patients were response evaluable. Overall, the majority of patients experienced a decrease in their target lesions with a disease control rate of 72%, comprising 16 patients with partial responses and 17 with stable disease. The objective response rate in the six evaluable biliary tract cancer patients was 67%, with the majority of patients experiencing disease control greater than six months. In the 11 CRC and 19 GEA patients, the objective response rates were 36% and 32%, respectively. The overall median progression-free survival was 5.2 months, with 27 of the 58 total patients still on study at the time of data cut-off. Among all patients, ZW25 was well tolerated as an outpatient therapy. All treatment-related adverse events occurring in 10% or more of patients were Grade 1 or 2.

15:01 EDT Essa Pharma presents new data on EPI-7386 at ESMO - ESSA Pharma presented new preclinical data on ESSA's lead Investigational New Drug candidate at the 2019 American Urological Association Annual Meeting. According to the presentation, EPI-7386 demonstrates: Activity in multiple in vitro full length androgen receptor and AR-V7 splice variant driven cellular models; Robust antitumor activity as a single agent and in combination with enzalutamide in the VCaP xenograft prostate cancer model; Antitumor activity in enzalutamide-resistant prostate cancer xenograft models, 22Rv1 and LNCaP95, with no antitumor activity, as expected, in a non-functional androgen receptor PC-3 prostate cancer xenograft model; Wide therapeutic index as demonstrated by a broad dose response in the VCaP model; High plasma exposures in animal studies using a new suspension formulation.

14:53 EDT G1 Therapeutics presents data from Phase 2 trial of Trilaciclib, chemo combo - G1 Therapeutics reported preliminary overall survival data from the company's randomized Phase 2 trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer. In the trial, median overall survival for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin was 20.1 months, compared with 12.6 months for patients receiving chemotherapy alone. The randomized, open-label Phase 2 study of trilaciclib in combination with GC, a current standard of care for TNBC, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic TNBC. In this three-arm trial, all three groups received a chemotherapy regimen of GC. Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of overall response rate, progression-free survival and OS. Updated results from the trial showed that the addition of trilaciclib to chemotherapy resulted in a significant increase in OS in both treatment groups compared to chemotherapy alone. Compared to GC alone, OS was improved for both trilaciclib arms with median OS of 12.6 months, 20.1 months and 17.8 months, respectively. The median OS for Groups 2 and 3 combined was 20.1 months. The median OS for GC alone was consistent with historical data. PFS and ORR were consistent with previously reported data. The safety and tolerability of trilaciclib were consistent with previously reported data. There have been no serious adverse events attributed to treatment with trilaciclib in this trial. Patient-reported outcome measures related to anemia were improved in patients receiving trilaciclib versus patients receiving chemotherapy alone. As previously reported, primary endpoints were not met.

14:31 EDT Calithera Biosciences presents data from randomized Phase 2 ENTRATA study - Calithera Biosciences presented supporting data for its previously reported positive results from its randomized placebo-controlled Phase 2 ENTRATA study of telaglenastat in combination with everolimus in patients with advanced renal cell carcinoma. The telaglenastat-everolimus combination doubled the median progression-free survival in heavily pre-treated patients with advanced RCC and had a well-tolerated safety profile. Telaglenastat is the first glutaminase inhibitor to demonstrate clinical activity for the treatment of cancer. Calithera announced top-line results from the ENTRATA trial in June. Key demographics in patients enrolled in the phase 2 ENTRATA study were balanced between the two treatment arms and were heavily pre-treated, with a median of three prior lines of therapy for advanced metastatic disease including 70% with two or more prior tyrosine kinase inhibitors, and 68% with intermediate/poor MSKCC prognostic score. 88% of patients received prior PD-1/PD-L1 therapy. When added to everolimus, telaglenastat doubled the median PFS to 3.8 months as compared to 1.9 months for everolimus alone and reduced the risk of disease progression or death by 36%. The primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of less than or equal to 0.2 one-sided. Overall response per Response Evaluation Criteria in Solid Tumors version 1.1 was 2.2% vs. 0%, and stable disease was 56.5% vs. 47.8%. The secondary endpoint of overall survival is not yet mature. Frequency of all-grade adverse events in the telaglenastat-containing arm were comparable to that of everolimus alone. Grade 3 or higher adverse events occurred in 80.4% of patients in the telaglenastat plus everolimus arm versus 60.9% in the everolimus plus placebo arm. Adverse events leading to discontinuation of any study drug were comparable. The ENTRATA trial is a randomized, double-blind Phase 2 trial designed to evaluate the efficacy and safety of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one VEGFR-targeted TKI. Patients were randomized in a 2:1 ratio, and stratified by prior TKI treatment and MSKCC prognostic score. The trial enrolled 69 patients at multiple centers in the U.S. Telaglenastat is also being investigated in the CANTATA trial, a global, randomized, double-blind trial designed to evaluate the efficacy and safety of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic RCC who have been treated with one or two prior lines of systemic therapy including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the combination of nivolumab and ipilimumab. In April 2018, the U.S. Food and Drug Administration granted Fast Track designation to telaglenastat in this indication. The primary endpoint is progression-free survival by blinded independent review, and a key secondary endpoint is overall survival. Calithera plans to report top-line efficacy and safety data from the trial in the second half of 2020.

14:17 EDT Bristol-Myers announces efficacy data analysis from Phase 3 CheckMate -238 trial - Bristol-Myers Squibb announced results of a three-year analysis of efficacy data from the Phase 3 CheckMate -238 study evaluating adjuvant use of Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients with Stage III or Stage IV melanoma who were at high risk of recurrence following complete surgical resection. At three years of follow-up, Opdivo continues to demonstrate superior recurrence-free survival compared to Yervoy, the active control, with RFS rates of 58% and 45%, respectively. Distant-metastasis-free survival also continues to be significantly longer for Opdivo, with 36-month rates of 66% and 58%, respectively. Both RFS and DMFS benefit continue to be observed across key subgroups, including disease stages, BRAF mutation status and PD-L1 expression. No new safety data were generated as part of the 36-month analysis.

14:06 EDT Amgen announces new data evaluating novel investigational KRAS inhibitor - Amgen announced new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutant solid tumors. The data include the first evidence of anti-tumor activity reported in patients with colorectal cancer and appendiceal cancer, as well as previously presented non-small cell lung cancer findings. AMG 510 continues to be well-tolerated with no dose-limiting toxicities. The study enrolled 76 patients with KRAS G12C-mutant solid tumors. Data being presented at ESMO include a subset of 55 evaluable patients as of the July 2019 data cutoff, including CRC, appendiceal cancer and NSCLC patients from the Phase 1 study. Of the 55 patients, 29 had CRC. 12 patients with CRC received the target dose of 960 mg once daily and 10 remain on treatment. One patient in this dose cohort experienced a partial response and 10 had stable disease for a disease control rate of 92%. 13 of the evaluable patients with NSCLC received 960 mg, of which seven achieved a partial response at one or more timepoints and six achieved stable disease, for a disease control rate of 100%. Data across dosing cohorts also showed tumor responses in two evaluable patients with appendiceal cancer with one partial response and one experiencing stable disease. Among the 76 patients enrolled across treatment groups, 52 remain on treatment. The majority of treatment-related adverse events were grade 1 and 2. Only two TRAEs were grade 3. There were no grade 4 or higher TRAEs.