MUNICH—Bristol-Myers Squibb is looking to push its Opdivo-Yervoy combo further into colorectal cancer, and with new phase 2 data in previously untreated patients, it just might be able to.
Monday at the European Society for Medical Oncology annual meeting, the New Jersey drugmaker rolled out results showing that its immuno-oncology duo provoked responses in 60% of previously untreated patients with metastatic colorectal cancer that’s microsatellite instability-high (MSI-H) or mismatch repair deficient. About 4-5% of mCRC patients have those biomarkers, which make them less likely to benefit from conventional chemo.
Fouad Namouni, Bristol-Myers’ oncology development chief, called the study “groundbreaking,” and noted that in previous trials, PD-1 agents posted response numbers “in the mid-to-high 30s.”
Adding CTLA4 drug Yervoy almost doubled the response rate, which “hopefully will translate into a longer-term benefit with a manageable safety profile,” he said.
So far, the FDA has doled out three approvals in MSI-H cancers, though they’ve all been for previously treated patients. Merck was the first to win one, snagging a nod for its PD-1 player Keytruda last May that covered MSI-H tumors of any kind—not just colorectal—identified anywhere in the body with genetic testing.
Bristol followed with a more limited, colorectal-only OK for solo Opdivo in August, and it added a combo approval for Opdivo and Yervoy this July.
The new data, though, give the company a chance at earlier use, which generally comes along with a wider patient population that stays on treatment for longer. And Bristol, which recently ceded the immuno-oncology sales lead to its archrival Merck, wouldn’t mind that opportunity.
Meanwhile, BMS is trialing its one-two punch in several other cancer types, many of which it showcased at ESMO. The pharma giant trotted out positive data in melanoma, kidney cancer and bladder cancer, and it’s expecting phase 3 results in lung cancer, head and neck cancer, liver cancer in more in the not-too-distant future.
And while the Opdivo-Yervoy combo so far hasn’t lived up to Merck’s Keytruda-chemo pairing in the all-important lung cancer field, BMS has remained adamant that it’s on the right track.
“My vision of the treatment of cancer, it’s not going to be one or two agents,” Namouni said. “I really think we’re going to have to combine a number of modalities together in a rational way … to raise the bar.”