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.


The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% on standard rates when you register with Discount Code DPE19Fierce.

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.

Suggested Articles

Novartis is doing more portfolio pruning, offloading three endocrine drugs to Recordati.

Turns out, the FDA’s March rejection of Sanofi's Zynquista was just a preview of what would come for the SGLT class in Type 1 diabetes.

Indoco Remedies is not just getting the once over by the FDA but the twice-over as inspectors work through its plants and citations rain down.