Genentech, a member of the Roche Group, announced results from the Phase III IMpower132 study of TECENTRIQ plus pemetrexed and platinum-based chemotherapy for the initial treatment of people with non-squamous, non-small cell lung cancer. This interim analysis showed that TECENTRIQ and chemotherapy reduced the risk of disease worsening or death by 40% compared with chemotherapy alone. While a numerical improvement of 4.5 months for the co-primary endpoint of overall survival was observed, at this interim analysis statistical significance has not yet been met. The study will continue as planned, with final OS results expected next year. Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. “This is our third Phase III trial in non-squamous non-small cell lung cancer demonstrating that a TECENTRIQ-based regimen can help reduce the risk of disease progression for people living with this disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We will discuss these results with health authorities globally.”
Monday, September 24, 2018
AstraZeneca says EC grants marketing authorization for Imfinzi
AstraZeneca and MedImmune announced that the European Commission has granted marketing authorisation for Imfinzi as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer in adults whose tumours express PD-L1 on greater than or equal to1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy. The approval is based on results from the Phase III PACIFIC trial. The approval follows the positive opinion on 27 July 2018 from the CHMP of the European Medicines Agency. The most common adverse reactions of Imfinzi versus placebo were cough, upper respiratory tract infections and rash. 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo. Imfinzi is approved for the treatment of patients with unresectable, Stage III NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.
Citi sees about five times upside for Amarin after Vascepa trial succeeds
Citi analyst Joel Beatty said he views Amarin as a “strong acquisition candidate” after the REDUCE-IT outcomes trial of Vascepa succeeded and noted that he previously stated that Amarin could be worth $14 per share in this scenario. The 25% RRR on the primary endpoint exceeded his expectations as well as that of “most bulls,” contends Beatty, who has a Buy rating and $5 price target on the stock. Near noon, Amarin shares are up 238% to $10.12.
Spectrum announces preliminary poziotinib data from Phase 2 study
Spectrum Pharmaceuticals announced preliminary poziotinib data from the University of Texas, MD Anderson Cancer Center Phase 2 non-small cell lung cancer study which were released during an oral presentation at the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. The MD Anderson study is the single largest data set of patients with an exon 20 mutation in EGFR or HER2. In the interim analysis presented at the WCLC, the following observations were made: This phase II study demonstrates high anti-tumor activity for poziotinib in metastatic, heavily pretreated EGFR exon 20 mutant NSCLC, a group for which no targeted agents have proven effective to date with best response of PR in 55% of evaluable patients. Median PFS 5.5m; durable responses observed with 6 treated for greater than1year thus far. Compares favorably to historical ORR rates of less than8% approved TKIs and less than19% for standard of care 2L agents. Significant activity also observed in HER2 exon 20-mutant NSCLC with initial responses observed in 50% evaluable patients and median PFS 5.1m. EGFR-related toxicities were manageable and required dose reductions in 60%. Discontinuation due to poor tolerance was rare. Encouraging activity has prompted a confirmatory, international, multicenter study in EGFR and HER2 exon 20 mutant NSCLC patients which is currently enrolling, including a first-line cohort, and development of a separate pan-tumor basket study. The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas, MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study with active sites in the United States and future centers planned in Canada and Europe. The overall poziotinib clinical development program is focused on four pillars, including previously treated NSCLC, first-line treatment of NSCLC, combination therapy and treatment of other solid tumors.
Elliott teaming with new firm in pursuit of Athenahealth, Dealreporter says
Elliott has now partnered with a new private equity firm to pursue Athenahealth and is no longer teaming up with Bain, as the two firms appeared to have divergent views on the company’s valuation, said Dealreporter, according to contacts.
J&J talc cancer case in California ends in mistrial
Johnson & Johnson’s latest trial over allegations that its baby powder causer cancer ended in a mistrial, as jurors could not come to an agreement on a verdict, Bloomberg reports. A state judge in Pasadena, California, declared a mistrial after jurors deadlocked on plaintiff Carolyn Weirick’s ask for at least $25M in damages over her mesothelioma, which she claims she developed from asbestos-laced baby powder, the report says.
https://thefly.com/landingPageNews.php?id=2794655
Teladoc to host investor day
Investor Day to be held in New York on September 27 at 10 am. Webcast: https://event.on24.com/eventRegistration/EventLobbyServlet?target=reg20.jsp&referrer=http%3A%2F%2Fir.teladoc.com%2Fnews-and-events%2Fevents-and-presentations%2F&eventid=1819425&sessionid=1&key=12F8758D6016673AE6CF63017702EFA4®Tag=&sourcepage=register
https://thefly.com/landingPageNews.php?id=2794679
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