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BioCentury Extra
As published Friday, October 21, 2016 4:32 PM PST

  • Keytruda passes Phase III bladder cancer test

    Merck & Co. Inc. (NYSE:MRK) said PD-1 mAb Keytruda pembrolizumab met the co-primary overall survival (OS) endpoint in the Phase III KEYNOTE-045 trial to treat bladder cancer. The pharma stopped the study early on the recommendation of an independent data monitoring committee.

    The open-label KEYNOTE-045 evaluated Keytruda vs. investigator's choice of chemotherapy to treat metastatic, locally advanced or unresectable urothelial cancer that recurred or progressed following platinum-based chemotherapy. Merck said it plans to present the data at an upcoming medical meeting.

    KEYNOTE-045's second co-primary endpoint is progression-free survival (PFS). Merck spokesperson Pamela Eisele did not respond to an inquiry about the outcome on that endpoint. She also declined to give a timeline for regulatory submissions for Keytruda in the indication.

    The drug is approved to treat melanoma and has accelerated approvals for non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1, and for head and neck cancer.

    In May, FDA granted accelerated approval to PD-L1 inhibitor Tecentriq atezolizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) to treat locally advanced or metastatic urothelial carcinoma that progressed on or after platinum-based chemotherapy (see BioCentury Extra, May 18).

    AstraZeneca plc (LSE:AZN; NYSE:AZN) expects data in 2018 from the Phase III DANUBE study of durvalumab (MEDI4736), a mAb against PD-L1, as a first-line treatment for bladder cancer.

  • FDA again reviewing Newron's Xadago for Parkinson's

    Newron Pharmaceuticals S.p.A. (SIX:NWRN) said FDA accepted its re-submitted NDA for Parkinson's disease candidate Xadago safinamide. Its PDUFA date is March 21, 2017.

    In March, the agency issued a complete response letter for the compound, which was under review as an add-on therapy for early and mid to late stage PD in patients who are inadequately managed on their current treatments. Safinamide is an alpha-aminoamide derivative that acts as a reversible monoamine oxidase B (MAO-B) and dopamine reuptake inhibitor while reducing glutamatergic activity. Newron resubmitted the application in September (see BioCentury Extra, March 29).

    US WorldMeds LLC (Louisville, Ky.) holds U.S. rights to Xadago. Newron's partner Zambon Co. S.p.A. (Bresso, Italy) markets the drug in several European countries.

    Newron added CHF1.05 to CHF20.75 on Friday.

  • Opdivo gets PDUFA date for bladder cancer

    On Friday, Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted and granted Priority Review to its sBLA for Opdivo nivolumab to treat bladder cancer in a second-line setting. Its PDUFA date is March 2, 2017.

    The sBLA covers use of Opdivo in patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing chemotherapy. The PD-1 inhibitor has breakthrough therapy designation in the indication. BMS based its submission on CheckMate -275, a single-arm Phase II study.

    FDA has already granted accelerated approval to another checkpoint program, the PD-L1 inhibitor Tecentriq atezolizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). It was approved in the second-line setting for bladder cancer in May.

    Opdivo has FDA approval to treat melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and classical Hodgkin's lymphoma.

    Also on Friday, Merck & Co. Inc. (NYSE:MRK) said PD-1 mAb Keytruda pembrolizumab met a co-primary endpoint in a Phase III trial to treat bladder cancer as a second-line therapy, and stopped the trial early (see above).

  • Arbutus returns cyclophilin inhibitor to NeuroVive

    NeuroVive Pharmaceutical AB (SSE:NVP; Pink:NEVPF) regained rights to NVP018 from Arbutus Biopharma Corp. (NASDAQ:ABUS) as the companies terminated a 2014 deal to develop the compound for HBV.

    The exclusive, worldwide rights to NVP018 were obtained in 2014 by OnCore Biopharma Inc., which had hoped to develop the compound as part of a multimodal approach to curing HBV. OnCore, which was formed by a group of former Pharmasset Inc. executives, merged with Tekmira Pharmaceuticals Corp. in 2015 to form Arbutus (see BioCentury, Sept. 15, 2014).

    In its 10-K filing last March, Arbutus said it discontinued development of the orally available sangamide-based cyclophilin inhibitor in October 2015 after concluding cyclophilins do not play a role in chronic HBV infection.

    NeuroVive gained SEK0.12 to SEK3.50 on Thursday, while Arbutus gained $0.17 to $3.25.

  • Alkermes jumps on MDD readout

    Alkermes plc (NASDAQ:ALKS) rose $12.11 (28%) to $55.62 on Friday after it said the higher of two doses of ALKS 5461 met the primary endpoint of the FORWARD-5 trial of the compound as adjunctive therapy for major depressive disorder (MDD). The company reported the news after market close Thursday (see BioCentury Extra, Oct. 20).

    Based on the 151.5 million shares outstanding reported in Alkermes' latest quarterly report, Friday's stock move added about $1.8 billion to the company's market cap.

    ALKS 5461 combines buprenorphine with samidorphan (ALKS 33), a mu opioid receptor (OPRM1; MOR) antagonist. It has Fast Track designation from FDA to treat refractory MDD.

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