Bristol-Myers Squibb announces nivolumab results

Bristol-Myers Squibb has announced the results of its trial into nivolumab.

The study assesses the drug in combination simultaneously with sequentially with Yervoy, with the solution aiming to cure patients with advanced melanoma.

Of patients who received the dose in the concurrent regimen, 53 per cent confirmed objective responses by mWHO criteria, with tumours shrinking by a minimum of 80 per cent by the time of the first clinical treatment assessment (12 weeks).

For response-evaluable patients throughout all concurrent cohorts, 40 per cent had objective responses, while 16 patients experienced tumour shrinkage of at least 80 per cent after 12 weeks.

The estimated one-year survival rate across all concurrent cohorts was 82 per cent, while grade 3-4 treatment-related adverse events were found in 53 per cent of patients on the concurrent regimen and 18 per cent on the sequenced regimen.

Brian Daniels, senior vice president, global development and medical affairs at Bristol-Myers Squibb, said: “An unmet medical need remains for many types of advanced cancer and Bristol-Myers Squibb is committed to leading advances in a new field of research, immuno-oncology, which is a rapidly evolving, innovative treatment modality centered on harnessing the natural capabilities of a patient’s own immune system to fight cancer.

“Results from this Phase 1 study provide important insights about the potential of combinations in immuno-oncology and deepen our understanding of how cancer cells evade the immune system.”

Bristol-Myers Squibb is developing a pipeline of compounds to directly motivate the immune system across a range of cancers, including a development program for nivolumab.

Its phase 3 development program for Yervoy is still ongoing, including Phase 3 trials in adjuvant melanoma, NSCLC and metastatic castrate-resistant prostate cancer.

Dr Jedd D Wolchok, Ludwig centre for cancer immunotherapy at Memorial Sloan-Kettering Cancer Center, said that the work is the first clinical trial to evaluate the safety and efficacy of combining two immune-checkpoint inhibitors.

Posted by Neil Clark