Dive Brief:
- Bristol Myers Squibb’s Opdivo reduced the risk of death or a recurrence of melanoma by 58% in trial results released Wednesday.
- Researchers presented the data at a medical meeting in Scotland, giving doctors and investors the first detailed view of the findings. Bristol Myers previously had announced in September that the Phase 3 trial met its primary endpoint.
- The study, dubbed CheckMate-76K, included patients with stage 2B or 2C melanoma who had a procedure to completely remove cancer cells and then received treatment with either Opdivo or a placebo. After one year, 89% of the patients on Bristol Myers’ drug survived without a recurrence of disease, compared with 79% of patients on placebo.
Dive Insight:
The results will help Bristol Myers as it tries to catch up with Merck, which won approval to sell Keytruda for the same group of patients last December. Bristol Myers’ Opdivo won Food and Drug Administration approval in 2017 for patients with more advanced cases of melanoma.
Both drugs are already widely used in metastatic cancers; sales of Merck’s Keytruda reached $5.3 billion in the second quarter, while Opdivo brought in $2.1 billion. The developers are hoping to boost those numbers by moving their drugs into earlier lines of care, relying on their ability to stop cancers from returning. In melanoma, for instance, Keytruda was cleared by regulators for stage 2B or 2C melanoma after reducing the risk of recurrence or death by 35% in clinical testing.
Still, the companies are facing some reluctance in earlier-stage tumors, as doctors weigh the benefits against side effects and the need for patients to get infusions every three to four weeks, Cantor Fitzgerald analyst Louise Chen wrote in an Oct. 20 note to investors.
That reluctance partially stems from a longrunning debate in the oncology community as to whether disease-free survival — a widely used study goal in early-stage cancers — is a legitimate proxy for a treatment’s ability to keep patients alive longer. That hasn’t always been the case, which has led to criticism of the endpoint from some oncologists.
Longer-term studies that show a survival benefit for the medicines should help drive greater adoption of the drugs, Chen wrote. Bristol Myers said its latest study found no new safety issues with Opdivo. Researchers found that 10% of patients in the treatment arm had serious side effects considered grade 3/4, compared with 2% in the placebo arm.
Bristol Myers has had a busy year in oncology, with the company announcing plans to buy targeted cancer drug maker Turning Point Therapeutics for $4.1 billion less than two months after scrapping a $2 billion partnership with Nektar Therapeutics. Bristol Myers also recently won FDA approval for Opdualag, a skin cancer treatment that combines Opdivo with a new antibody medicine.