- A new type of cancer immunotherapy, when added to Bristol Myers Squibb's drug Opdivo, succeeded in a late-stage clinical study of people with melanoma that's spread and can't be surgically removed, the company said Thursday. Bristol Myers plans to discuss the results with the Food and Drug Administration to determine whether the drug is ready for review.
- Without detailing specific findings, Bristol Myers said the combination therapy kept patients' disease in check longer than Opdivo alone. Opdivo was the second so-called PD-1 inhibitor to be approved in the U.S. for use treating melanoma, and the third immunotherapy cleared for that disease.
- Relatlimab, as the new immunotherapy is known, turns off a protein on immune cells called LAG-3 that stops them from attacking tumor cells. In completing a late-stage trial, Bristol Myers is a step ahead of rivals from Regeneron and Merck & Co. in proving out a drug that blocks LAG-3.
Cancer immunotherapies like Opdivo, Merck's Keytruda, and Yervoy, another Bristol Myers drug, have significantly advanced treatment for many different types of tumors. Experimental drugs aimed at other immune pathways haven't been quite as successful. Relatlimab has a shot at changing that with this first cut of Phase 3 data.
Whereas Opdivo and Keytruda help prevent tumor cells from escaping the body's immune response, Yervoy and now relatlimab are designed to turn on those immune cells. Bristol Myers believes the two types of drugs are more effective together, having bet heavily on pairings of Opdivo and Yervoy in melanoma and other cancers.
The trial of relatlimab, dubbed RELATIVITY-047, enrolled 714 patients who had never been treated previously. Half received a fixed-dose combination of Opdivo and relatlimab, while the other half got Opdivo alone. The study measured progression free survival, or how long patients lived without their melanoma getting worse. Overall survival and rates of remission were secondary goals of the study.
Bristol Myers didn't release detailed numbers, although to beat Opdivo alone it would need to keep melanoma from spreading for a median of more than 5.1 months, as was reported in the company's CHECKPOINT-066 trial. Median overall survival in that trial was 37.5 months. Overall survival follow-up in RELATIVITY-047 is still ongoing.
The company was able to extend survival by combining Opdivo with Yervoy, which together led to median progression-free survival of 11.5 months. But the combination is known for being particularly toxic, as 59% of patients in its pivotal trial experienced severe side effects.
The Opdivo-relatlimab combination therefore may not need to significantly outperform Opdivo-Yervoy combination on effectiveness if it is more tolerable. In a press release, Bristol Myers stated that the combination "was well-tolerated and there were no new safety signals reported."
Bristol Myers' ambitions for relatlimab go beyond melanoma. There are 17 other active Phase 2 or 3 trials of the treatment, including tests in blood cancers and in kidney cancer.
Yet the company will have competition. Regeneron is testing an experimental drug called REGN3767 in the clinic, although its most advanced study is the university consortium breast cancer study called I-SPY. The biotech's other trials are mainly testing REGN3767 in combination with its marketed drug Libtayo.
Merck's MK-4280 is in four mid-stage trials, while a treatment from Boehringer Ingelheim is being evaluated in a Phase 2 trial together with an experimental PD-1 drug.
Macrogenics, Incyte, and partners Novartis and Immutep have candidates in mid-stage testing as well.