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08:13 EDT Immunocore presents three-year overall survival data from KIMMTRAK Phase 3 trial - Immunocore announces that the three-year overall survival data from the KIMMTRAK Phase 3 trial in previously untreated HLA-A*02:01 positive patients with metastatic uveal melanoma has been published in The New England Journal of Medicine, and presented as a late breaking abstract in a mini oral session at the European Society for Medical Oncology Congress 2023. In the Phase 3 trial follow up - the longest of any randomized trial for metastatic uveal melanoma - the three-year OS rate was 27% in the KIMMTRAK arm, versus 18% in the control arm. The median OS was 21.6 months on KIMMTRAK, versus 16.9 months on investigator's choice. The OS Hazard Ratio avored KIMMTRAK, HR=0.68, over investigator's choice. Overall response rate remained in favor of KIMMTRAK when compared with the control arm and the median duration of response for KIMMTRAK patients was 11.1 months. The rate of disease control was also higher in the KIMMTRAK arm versus the control arm. Over half of all patients treated with KIMMTRAK were treated beyond initial radiographic progression. The trial evaluated circulating tumor DNA clearance as a predictor of overall survival. ctDNA clearance on KIMMTRAK occurred in 37% of evaluable patients and was associated with longer OS. No new adverse events related to long-term KIMMTRAK treatment were observed. The rate of discontinuation due to treatment-related AEs continued to be lower in the KIMMTRAK arm than for the control arm. There were no treatment-related deaths. In a separate poster at the Congress, an analysis of the role of subsequent therapy from the Phase 3 trial in first-line mUM patients confirmed that the survival benefit mostly comes from KIMMTRAK treatment rather than subsequent therapy. A further poster included an analysis from the Phase 1b study in previously treated metastatic cutaneous melanoma patients, demonstrating the safety and activity of KIMMTRAK by BRAF mutation status. A third poster investigated the reprogramming effect of KIMMTRAK on immunosuppressive M2 macrophages from Phase 2 unresectable or metastatic uveal melanoma patients, as well as in vitro.

08:06 EDT Updated results from BEGONIA Phase Ib/II trial presented at ESMO - Updated results from the BEGONIA Phase Ib/II trial for the cohort of patients treated with datopotamab deruxtecan plus Imfinzi showed that the combination demonstrated durable tumour responses and no new safety signals in patients with previously untreated advanced or metastatic triple-negative breast cancer with six months additional follow-up from the previous data cut-off. These data will be presented in a mini oral session at the European Society for Medical Oncology 2023 Congress in Madrid, Spain. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate being jointly developed by AstraZeneca and Daiichi Sankyo. Approximately 300,000 people worldwide are diagnosed annually with TNBC, the most aggressive breast cancer subtype. Less than half of patients with metastatic TNBC respond to current 1st-line treatment options which can include chemotherapy alone or in combination with an immunotherapy. Among patients with tumours that do respond to initial treatment, disease progression is common and rapid, often occurring within two years. Results showed that datopotamab deruxtecan plus Imfinzi, an anti-PD-L1 therapy, demonstrated a confirmed objective response rate of 79% including six complete responses and 43 partial responses. Responses were observed regardless of PD-L1 expression level. Median progression-free survival was 13.8 months and median duration of response was 15.5 months with 11.7 months of follow-up. The safety profile of datopotamab deruxtecan in combination with Imfinzi was consistent with the known safety profiles of both agents. Grade 3 or higher treatment-emergent adverse events occurred in 57% of patients. There were three interstitial lung disease events adjudicated as drug-related by an independent committee including two Grade 2 events and one Grade 1 event. In Arm 7 of the BEGONIA trial, the majority of patients had tumours with low PD-L1 expression. Seven patients had tumours with high PD-L1 expression. As of the 2 February 2023 data cut-off, 29 patients remained on study treatment.

08:00 EDT Results from primary analysis of the DUO-E Phase III trial presented at ESMO - Results from the primary analysis of the DUO-E Phase III trial showed that IMFINZI plus platinum-based chemotherapy, followed by either IMFINZI monotherapy or IMFINZI plus LYNPARZA, both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone in the overall trial population of patients with newly diagnosed advanced or recurrent endometrial cancer. These results will be presented today in a proffered paper session at the 2023 European Society for Medical Oncology Congress in Madrid, Spain and simultaneously published online in the Journal of Clinical Oncology. In the overall trial population, results showed that treatment with IMFINZI plus chemotherapy followed by IMFINZI plus LYNPARZA and treatment with IMFINZI plus chemotherapy followed by IMFINZI monotherapy demonstrated a reduction in the risk of disease progression or death, by 45% and 29%, respectively, versus chemotherapy alone. Median PFS was 15.1 months in the IMFINZI plus LYNPARZA Arm and 9.6 months in the Control Arm. Mismatch repair status is a biomarker of interest in endometrial cancer, therefore a prespecified exploratory subgroup analysis by MMR status was conducted in DUO-E. Results from the analysis of mismatch repair proficient patients showed a reduction in the risk of disease progression or death in both the IMFINZI plus LYNPARZA and the IMFINZI Arms, by 43% and 23%, respectively, versus the Control Arm. Median PFS was 15 months in the IMFINZI plus LYNPARZA Arm and 9.7 months in the Control Arm. Results from the analysis of mismatch repair deficient patients showed a similar reduction in the risk of disease progression or death in both the IMFINZI plus LYNPARZA and the IMFINZI Arms, by 59% and 58%, respectively, versus the Control Arm. Interim overall survival data showed a favorable trend for both treatment regimens in the overall population. PD-L1 is a known biomarker for IMFINZI in other indications and a prespecified analysis based on PD-L1 status showed, in the PD-L1 positive population, that treatment reduced the risk of disease progression or death by 58% and 37% in the IMFINZI plus LYNPARZA and the IMFINZI Arms, respectively, versus the Control Arm. Median PFS was 20.8 months in the IMFINZI plus LYNPARZA Arm and 9.5 months in the Control Arm. In the PD-L1 negative population, treatment reduced the risk of disease progression or death by 20% and 11% in the IMFINZI plus LYNPARZA and the IMFINZI Arms, respectively, versus the Control Arm. The safety and tolerability profiles of both regimens were broadly consistent with those observed in prior clinical trials and the known profiles of the individual medicines. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.

07:30 EDT Personalis presents initial findings from work with RACERx lung cancer study - Personalis announced the presentation of initial findings from its work with TRACERx lung cancer study, marking a substantial advancement in lung cancer circulating tumor DNA detection and management. The Personalis NeXT Personal cancer assay, created to detect and monitor residual and recurrent disease, demonstrated significantly improved detection rates for early-stage lung cancer, including lung adenocarcinoma, one of the most common and challenging subtypes of non-small cell lung cancer to identify in blood samples. The findings come from an analysis by Professor Charles Swanton, James Black, and other members of the TRACERx consortium. The findings were presented at the 2023 European Society for Medical Oncology Congress on October 21 in Madrid, Spain, and are the first publicly presented results from Personalis' collaboration with Cancer Research UK's Cancer Research Horizons, University College London, and the Francis Crick Institute. In this analysis, NeXT Personal showed significantly higher sensitivity in early-stage NSCLC patients compared to two previous publications on the TRACERx cohort. Pre-surgery, the assay demonstrated 100% sensitivity for ctDNA in pre-surgical non-LUAD samples and 81% pre-surgical ctDNA sensitivity for LUAD, one of the most common types of lung cancer but also one of the most challenging to detect in blood. The pre-surgical sensitivity for early-stage LUAD was up to 4X higher than in previous studies on the TRACERx cohort, depending on stage. This high sensitivity enhanced the assay's ability to detect recurrence and monitor lung cancer effectively. The study demonstrated that pre-surgical ctDNA levels with NeXT Personal could be used to classify early-stage lung cancer patients into lower- and higher-recurrence risk groups. Furthermore, the analysis showed that the ultra-low levels of ctDNA detection enabled by NeXT Personal were critical to determining patient recurrence risk. For example, LUAD patients who were ctDNA-negative before surgery with NeXT Personal strikingly exhibited a 100% 5-year overall survival rate and 94% relapse-free survival rate in the TRACERx cohort. In comparison, patients who were ctDNA-positive prior to surgery had a high risk of cancer recurrence over 5 years. The results presented at ESMO also showed that NeXT Personal enabled earlier detection of residual or recurrent lung cancer after surgery in the TRACERx cohort. The results show a median lead time of approximately 6 to 11 months for ctDNA detection ahead of traditional imaging, and significantly longer than previous TRACERx results. The ability to identify potential recurrence months earlier offers the possibility to intervene and accelerate treatment in high-risk patients. The promise of helping lung cancer patients throughout their journey Overall, the TRACERx results raise the potential of using NeXT Personal to help inform patient management throughout the patient journey, from pre-surgery to post-surgery and longer-term monitoring.