I was a little bit surprised how quickly INCY was able to get SPA for Jakafi in pancreatic cancer ph3 trial. They said they got it in Nov 2013. Ph2 result was announced in late August, which means FDA didn't have any issue with proposed SPA.
Incyte Corporation and MedImmune, the global biologics research and development arm of AstraZeneca, announced today that they have entered into a clinical study collaboration. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.
…MedImmune and Incyte will collaborate on a non-exclusive basis on the study, to evaluate the combination in multiple solid tumors including metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer.
The Phase I part of the trial is expected to establish a recommended dose regimen of both MEDI4736 and INCB24360 and the Phase II part of the study will assess the safety and efficacy of the combination… The study will be co-funded equally by Incyte and MedImmune and conducted by Incyte.
LLY/INCY Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib (JAK1/2) in Moderate to Severe Rheumatoid Arthritis
INDIANAPOLIS, Dec. 9, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment. The study included patients with moderately-to-severely active rheumatoid arthritis (RA) who previously failed one or more tumor necrosis factor (TNF) inhibitors and who were taking stable doses of conventional disease-modifying anti-rheumatic drug (cDMARD) therapy. The companies will share results of several ongoing Phase 3 studies in various disclosures in 2015.
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The incidence of serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A higher incidence of treatment-emergent adverse events was observed with baricitinib compared to placebo. The most common adverse events observed with baricitinib were headache, upper respiratory tract infection and nasopharyngitis. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study.