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FDA Approves Bristol Myers Antibody Combination for Melanoma
Other recent FDA approvals include Novartis’ prostate cancer drug and a second indication for Merck’s Keytruda for advanced endometrial carcinoma.
FDA recently approved Bristol Myers Squibb’s antibody combination, Opdualag (nivolumab and relatimab-rmbw), for adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
The agency based its approval on the RELATIVITY-047 trial, which evaluated Opdualag in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma compared to nivolumab alone.
Patients 12 years of age and older who weigh at least 88 pounds received 480 milligrams of nivolumab and 160 milligrams relatimab every four weeks. But FDA has not yet established the recommended dose for patients who weigh less than 88 pounds.
Overall, the trial demonstrated a statistically significant improvement in progression-free survival (PFS) for Opdualag compared to nivolumab. Median PFS was 10.1 months in the Opdualag group and 4.6 months in the nivolumab group. The secondary endpoint of median overall survival (OS) was not statistically significant.
The most common adverse reactions of Opdualag were mild and the most common laboratory abnormalities, which occurred in less than 20% of patients, were decreased hemoglobin, decreased lymphocytes, increased AST, increased ALT, and decreased sodium.
“Since the approval of the first immune checkpoint inhibitor more than ten years ago, we’ve seen immunotherapy, alone and in combination, revolutionize the treatment of patients with advanced melanoma,” F. Stephen Hodi, MD, director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber Cancer Institute, said in the announcement.
“Today’s approval is particularly significant, as it introduces an entirely new combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1,” Hodi continued.
FDA Approves Prostate Cancer Drug
FDA recently approved Novartis’ Pluvicto to treat adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC).
The agency based its decision on the VISION trial, which studied Pluvicto plus best standard of care (BSoC) or BSoC alone in patients with progressive PSMA-positive mCRPC. All patients were previously treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
Overall, the trial demonstrated statistically significant improvement in the primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS). Median OS was 15.3 months in the Pluvicto plus BSoC group and 11.3 months in the BSoC group.
The most common adverse events were mild. FDA’s recommended Pluvicto dose is 200 millicurie intravenously every six weeks, or until disease progression or unacceptable toxicity.
FDA Approves Merck’s Keytruda For Advanced Endometrial Carcinoma
FDA recently approved Merck’s Keytruda for patients with microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR) advanced endometrial carcinoma.
The agency based its approval on the KEYNOTE-158 trial, which enrolled 90 patients with unresectable or metastatic MSI-H or dMMR endometrial carcinoma who received at least one dose of Keytruda.
Researchers found that the objective response rate (ORR) was 46% for patients in the Keytruda group, including a complete response of 12% and a partial response of 33% at a median follow-up of 16 months. Of these patients, 68% had responses lasting 12 months or longer and 44% had responses 24 months or longer.
“This FDA approval is great news for women facing advanced endometrial cancer,” Scot Ebbinghaus, MD, vice president of clinical research at Merck, said in the announcement.
“We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda as monotherapy and in combination, with two approved indications in this area. We remain committed to pursuing meaningful advances in gynecologic and breast cancers through our portfolio of medicines,” Ebbinghaus continued.
This approval is the second indication for Keytruda in endometrial cancer. The drug is also indicated in combination with Lenvima to treat patients with advanced endometrial carcinoma that is not MSI-H or dMMR.
Merck is currently advancing its broad portfolio in gynecologic and breast cancers with an extensive clinical development program for Keytruda and various other investigational and approved medicines across these areas.
