On 15 February, the likelihood of approval (LoA) by the FDA of Bristol Myers Squibb’s Opdivo (nivolumab) in endometrial cancer dove by 13 points. An investigator-led Phase Ib/IIa trial testing Opdivo alone or in combination with Clovis Oncology’s PARP inhibitor Rubraca (rucaparib) was terminated as per a 12 February update on ClinicalTrials.gov. This update prompted Opdivo’s LoA score to change to 11% from 24%, since the primary endpoint was not achieved as per the trial entry.
Opdivo is approved in several settings across indications spanning non-small cell lung cancer (NSCLC), melanoma and renal cell carcinoma among others. Apart from the aforementioned Phase Ib/IIa study Opdivo is still being evaluated in several investigator-initiated trials enrolling endometrial cancer patients either as a monotherapy, or in combination with BMS’ other drugs like the IDO-1 inhibitor BMS-986205, and CTLA-4 inhibitor Yervoy (ipilimumab). Other trials led by Clovis and Compugen continue to explore Opdivo combinations in solid tumours, including endometrial cancer.
The LoA benchmark in the endometrial cancer indication is 18%. The LoA score is calculated by GlobalData’s analysis that uses a combination of machine learning and a proprietary algorithm. Merck’sPD-1 inhibitor Keytruda (pembrolizumab), one of Opdivo’s key competitors, is approved to treat microsatellite instability-high (MSI-high) or mismatch repair deficient cancer (dMMR) solid tumours, including endometrial cancer, that have progressed on prior treatment and are without any options. For those endometrial cancer patients with tumours that are not MSI-high or dMMR, Keytruda is approved in combination with Eisai’s Lenvima (lenvatinib) for patients who have disease progression on systemic therapy and are not candidates for curative surgery or radiation.
Manasi Vaidya is a Senior Reporter for Clinical Trials Arena 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.