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12:56 EDT Pfizer, EMD Serono announce publication of Phase 3 data for BAVENCIO plus INLYTA - Merck KGaA, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, and Pfizer announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine. The combination of BAVENCIO and INLYTA significantly extended median progression-free survival by more than 5 months compared with SUTENT as a first-line treatment for patients with advanced renal cell carcinoma, irrespective of PD-L1 expression. Further, the objective response rate was doubled with BAVENCIO+INLYTA versus SUTENT in this population. The study is continuing for the other primary endpoint of overall survival. Additional data presented at the 2019 Genitourinary Cancers Symposium reinforce the consistency of the PFS and ORR results across patient subgroups, including patients with favorable, intermediate and poor prognoses as well as those with PD-L1-positive or negative tumors. In subgroup analyses, approximately two-thirds of patients with favorable risk achieved a complete or partial response with BAVENCIO+INLYTA. Median PFS for these patients is not yet estimable. BAVENCIO+INLYTA also extended median PFS2, defined as the time from randomization to disease progression on next-line therapy and increased median duration of response by more than four months in the overall population. Adverse events of grade 3 or higher during treatment occurred in 71.2% of patients in the BAVENCIO+INLYTA arm and 71.5% in the SUTENT arm. In the combination arm, 9.0% of patients experienced grade 3 or higher immune-related adverse events. Grade 5 events occurred in three patients in the BAVENCIO+INLYTA arm and in one patient in the SUTENT arm. There were fewer discontinuations due to adverse events that occurred during treatment with BAVENCIO+INLYTA, compared with SUTENT. On February 11, 2019, the alliance announced that the U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for BAVENCIO in combination with INLYTA for patients with advanced RCC. The application has been given a target action date in June 2019. A supplemental application for BAVENCIO+INLYTA in unresectable or metastatic RCC was submitted in Japan on January 30, 2019. In December 2017, the FDA granted Breakthrough Therapy Designation for BAVENCIO in combination with INLYTA for treatment-naive patients with advanced RCC. Despite available therapies, the outlook for patients with advanced RCC remains poor.

12:42 EDT Aveo Pharmaceuticals presents TIVO-3 trial topline results - Aveo Oncology announced the presentation of data from the Phase 3 TIVO-3 study of tivozanib versus sorafenib in refractory advanced or metastatic renal cell carcinoma. The data were presented at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium held February 14-16, 2019 in San Francisco. The TIVO-3 trial is a Phase 3 randomized, controlled, multi-center, open-label study designed to compare tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic renal cell carcinoma. The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival. Tivozanib demonstrated a 44% improvement in median PFS and 26% reduction in the risk of progression or death. Median PFS was 5.6 months for tivozanib compared to 3.9 months for sorafenib. The TIVO-3 trial enrolled patients with RCC who have failed at least two prior regimens. Among these, approximately 26% of patients received checkpoint inhibitor therapy in earlier lines of treatment. PFS for tivozanib was longer than sorafenib both in patients who received prior CPI therapy and those who received two prior VEGF TKI therapies. Patients who received prior CPI therapy had a median PFS of 7.3 months with tivozanib and 5.1 months with sorafenib. One- and two-year PFS in patients who received tivozanib following CPI therapy was 35% and 25%, respectively, and 4% and n/a for patients receiving sorafenib following CPI therapy at those respective time periods. The secondary endpoint of overall response rate for patients receiving tivozanib was 18% compared to 8% for patients receiving sorafenib. Median duration of response in patients receiving tivozanib was not reached and was 5.7 months for patients receiving sorafenib. DOR probability at 1 year was 71% and 46% for tivozanib and sorafenib, respectively, and 55% and 0% at two years. The analysis of the secondary endpoint of overall survival was not mature at the time of the final PFS analysis, and currently reflects about 50% of potential OS events. As previously disclosed, the updated preliminary OS analysis conducted at an October 4, 2018 data cutoff date, which included additional patients previously lost to follow-up, showed a non-statistically significant difference in OS favoring sorafenib. The company intends to conduct an additional interim OS analysis in August 2019, the results of which are expected to be reported in the fourth quarter of 2019. Tivozanib was generally well-tolerated, with grade 3 or higher adverse events consistent with those observed in previous tivozanib trials. Infrequent but severe adverse events reported in greater number in the tivozanib arm were thrombotic events similar to those observed in previous tivozanib studies. The most common adverse event in patients receiving tivozanib was hypertension, an adverse event known to reflect effective VEGF pathway inhibition.