BMS and J&J build on immuno-oncology alliance with new Opdivo-Darzalex combo trials

Bristol-Myers Squibb building
BMS is expanding its alliance with J&J to test immuno-oncology combination treatments.

Ever since Bristol-Myers Squibb won FDA approval for the PD-1 inhibitor Opdivo in 2014, the company has been busy locking up partnerships to test the immuno-oncology product in combo cocktails. Now, BMS is building on one of its biggest alliances, formed with Johnson & Johnson’s Janssen unit back in July.

Bristol-Myers says it plans to test Opdivo along with Janssen’s Darzalex in multiple myeloma, as well as several solid tumor types. Those include lung cancer—where Opdivo chalked up a major failure last year as a solo therapy—plus colorectal cancer, triple-negative breast cancer and pancreatic cancer. The two companies will start phase 1B/2 trials this year, according to a statement.

It’s step two in a joint research program that began with trials of Opdivo plus JNJ-64041757, Janssen’s experimental compound that’s derived from the bug Listeria monocytogenes.

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Darzalex, approved in late 2015, was the first immunotherapy to work by inhibiting CD38, a protein that’s present in most multiple myeloma cells. On its own, the drug is a certified hit, having proven to slash the progression of multiple myeloma by more than 60%. A string of impressive trial results since Darzalex’s initial approval has analysts and doctors predicting the drug will become the standard of care in multiple myeloma within a few years.

But clearly J&J sees plenty of opportunity for Darzalex beyond multiple myeloma. In addition to the BMS alliance, the company has launched a trial of Darzalex with Tecentriq, a new PD-L1 inhibitor made by Roche’s Genentech, in solid tumors. Genentech is also sponsoring a trial of the Tecentriq/Darzalex pair along with Celgene’s Revlimid in multiple myeloma.

It’s all part of a larger push in the pharma industry to chase potentially lucrative cancer combos. Merck & Co. has also joined the party, launching several studies of its PD-1 blockbuster, Keytruda, with other treatments. The company has 200 ongoing combination trials in 30 tumor types. The wide range of compounds it’s testing along with Keytruda includes Amgen’s herpes-based melanoma treatment Imlygic and Incyte’s experimental IDO inhibitor epacadostat.

As for BMS, the Opdivo/Darzalex tie-up could boost what’s already been impressive performance by the PD-1 blockbuster: Opdivo hauled in $2.5 billion in sales in the first nine months of 2016. In targeting lung cancer, the partnership could also redeem Opdivo's failure in a much-anticipated first-line lung cancer trial last year. After announcing those disappointing results, which dashed hopes of a lucrative first-line approval, Bristol-Myers said it would focus on Opdivo combos in that disease.

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