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Opdivo Plus Experimental Drug Combo Fails to Improve Survival, Response Rates in Patients With Advanced Melanoma


The use of bempegaldesleukin and Opdivo failed to meet its goal of significantly improving progression-free survival and responses to treatment, compared with Opdivo alone in patients with previously untreated unresectable or metastatic melanoma, according to data from an initial analysis of the phase 3 PIVOT IO-001 study.

Patients with previously untreated unresectable or metastatic melanoma, a form of skin cancer, did not derive a survival benefit after receiving first-line treatment with Opdivo (nivolumab) in combination with the novel therapy bempegaldesleukin when compared with Opdivo alone, according to a news release issued by Bristol Myers Squibb (BMS), the manufacturer of Opdivo.

The pharmaceutical company recently provided an update on the first analysis of findings from the phase 3 PIVOT IO-001 study, which was assessing the safety and efficacy of the doublet treatment versus Opdivo alone as a potential first-line treatment option for this patient population.

The data, however, showed that the use of the bempegaldesleukin and Opdivo combination failed to meet its goal of significantly improving progression-free survival (the time during and after treatment when the patient lives without disease progression) as well as objective response rate (the percentage of patients whose disease partially or completely responds to treatment) compared to single-agent Opdivo treatment. Moreover, the results demonstrated that there was little benefit in terms of overall survival improvements as well.

READ MORE: FDA Approves Opdualag, a New Fixed-Dose Combination Treatment, For Certain Patients With Skin Cancer

As a result, BMS and Nektar Therapeutics, the manufacturer of bempegaldesleukin, announced that they will unblind the PIVOT IO-001 study, meaning that the investigators and/or study participants will be informed of which treatment the patients have been receiving. Additionally, these findings have also led to the two companies making the decision to stop enrollment and unblind the ongoing PIVOT-12 trial, which was assessing the combination versus Opdivo alone in patients at high risk for disease recurrence after a complete resection of their melanoma.

The release noted that patients in each of those studies will be advised on their treatment options and allowed to stay on the treatment they were receiving if it’s agreed with their treatment team.

These results, according to the release, will not affect the other studies evaluating bempegaldesleukin plus Opdivo in patients with renal cell carcinoma, a type of kidney cancer, and bladder cancer.

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