The combination of Bristol Myers Squibb cancer drugs Opdivo and Yervoy landed FDA approvals for the first-line treatment of colorectal cancer and hepatocellular carcinoma. Several other products also expanded their approved uses in our recap of recent regulatory news.
Bristol Myers Squibb’s Opdualag paired with blockbuster immunotherapy Opdivo failed a clinical trial testing the regimen as an adjuvant therapy for patients whose melanoma has been surgically removed. While Opdualag is still projected to reach blockbuster status, it could face competition from a Regeneron Pharmaceuticals drug.
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Opdivo Qvantig, administered by injection in less than five minutes, is now FDA approved for most solid tumor indications covered by Opdivo, a 30-minute intravenous infusion. The new product will help Bristol Myers Squibb compete with biosimilars as Opdivo faces looming patent expiration.
Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.
Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.
BMS told Five Prime that it does not have current plans to further sponsor clinical development of the drug cabiralizumab after the failure of the combo trial, with BMS' Opdivo and chemotherapy, but would support some investigator-sponsored trials.
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The company said Thursday morning that its study failed to meet its primary endpoint in high-grade gliomas. Shares of the company fell more than 80 percent on the Nasdaq.
In an interview at the ASCO meeting, BeiGene chief adviser Eric Hedrick said the company is well-prepared for when it likely regains global rights to tislelizumab.
The drug was being tested in combination with radiation therapy among newly diagnosed patients with glioblastoma, a notoriously difficult-to-treat and invariably fatal disease.
In a call to following news of the deal, executives pointed to near-term launch opportunities and pipelines, but some analysts expressed concern about the loss of patent protection for Revlimid and Opdivo.
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The acquisition brings together two of the largest drugmakers in the country, both of which are major players in biopharma, particularly oncology.
The company plans to use the funding to support its various microbiome-based drug development programs in oncology, food allergy and bacterial infection.
Two drugs - Pfizer and Merck KGaA's Bavencio and AstraZeneca's Imfinzi - saw Phase III trials fail, while anticipated negative results prompted Roche to withdraw Tecentriq from regulatory review.
Kyoto University's Tasuku Honjo and MD Anderson's James Allison will share the prize for work that led to immunotherapy drugs like Keytruda and Yervoy.
Janssen halts lung cancer and myeloma trials, citing lack of clinical benefit and greater number of patient deaths in combo arm.