BMS halts Opdivo kidney cancer trial early
pharmafile | July 22, 2015 | News story | Research and Development |Â Â BMS, Bristol-Myers Squibb, European Commission, Kidney cancer, opdivo, renal cell carcinomaÂ
Bristol-Myers Squibb has stopped its Phase III study of its immunotherapy drug Opdivo in people with kidney cancer early after the treatment improved overall survival.
The phase III study investigated Opdivo (nivolumab) compared to Novartis’ Afinitor (everolimus) in 821 previously treated patients with advanced or metastatic renal cell carcinoma.
An independent data monitoring committee stopped the trial after concluding Opdivo showed superior overall survival in comparison to the control arm. BMS will now complete a full evaluation of the final data and publish the full results.
“The results of CheckMate -025 mark the first time an Immuno-Oncology agent has demonstrated a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options,” says Michael Giordano, senior vice president and head of development, oncology at Bristol-Myers Squibb. “Through our Opdivo clinical development program, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival.”
Opdivo is already indicated for unresectable or metastatic melanoma and disease progression. It is also available in the UK for metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
This week the European Commission approved Opdivo for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer after prior chemotherapy.
The approval is based on the results of CheckMate -017 and -063. In the Phase III CheckMate -017 study, Opdivo demonstrated superior clinical benefit across all endpoints.
This approval symbols the first major treatment advance in squamous cell NSCLC in more than a decade in Europe. This approval allows for the marketing of Opdivo in all 28 Member States of the EU.
“With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care,” says Emmanuel Blin, senior vice president, head of commercialisation, policy and operationsat Bristol-Myers Squibb. “Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal.”
Yasmita Kumar
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