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June 16, 2021

LoA Update: BMS’ Opdivo/relatlimab combination gets boost in approval likelihood in 1L melanoma after Phase II/III results at ASCO

The Likelihood of Apporval (LoA) for Bristol Myers Squibb’s Opdivo (nivolumab) combo with the anti-LAG3 antibody relatlimab climbed by 10 points to 49%, as of 9 June.

By Manasi Vaidya

The Likelihood of Apporval (LoA) for Bristol Myers Squibb’s Opdivo (nivolumab)  combo with the anti-LAG3 antibody relatlimab climbed by 10 points to 49%, as of 9 June. The change was due to Phase II/III study results presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting last week.

The Phase II/III study evaluated the ability of Opdivo and relatlimab administered as a single infusion, compared to Opdivo alone to treat previously untreated metastatic or unresectable melanoma.  The median progression-free survival (PFS) for the combination was 10.1 months compared to 4.6 months with Opdivo alone (hazard ratio=0.75; p=0.0055), as per a presentation on 6 June. Opdivo is currently approved to treat unresectable or metastatic melanoma either as a monotherapy or in combination with BMS’ anti-CTLA-4 antibody Yervoy (ipilimumab), and as an adjuvant therapy in certain settings in melanoma. The company will discuss Opdivo/relatlimab data with regulatory authorities to make the treatment available to patients, as per 19 May press release, but did not provide timelines. Relatlimab is estimated to earn $477m in 2027, as per GlobalData consensus forecasts. BMS’ market cap is $150.36bn.

Prior to the data release at ASCO, the combination’s LoA was 39%. The LoA is calculated by using a combination of machine learning and a proprietary algorithm, and considers characteristics like therapy area, indication and molecule type.

Manasi Vaidya is a Associate Editor for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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