Bristol-Myers Squibb yesterday experienced a contradictory day at the ESMO Congress currently held in Munich. The US-based group announced positive results from its Phase III CheckMate-214 clinical trial, conducted on patients with metastatic kidney carcinoma treated with Opdivo (nivolumab)-Yervoy (ipilimumab) combo therapy: with a follow-up of 30 months, 36% of patients were still alive. The same combo therapy has also been tested, with positive results, in the Phase III CheckMate-067 clinical trial on patients with advanced-stage melanoma and has reported a 53% survival rate with a follow-up of 48 months.
However, these positive news have been partially overshadowed by the announcement that the European authorities and the FDA are reportedly postponing the approval of the Opdivo-Yervoy combo on patients with lung cancer and TMB variation, and have requested BMS new data.
The delay could be offset and the combo therapy approved as early as February, however the announcement has raised concern within the financial community and has caused BMS’ shares to plunge, with a 6% decrease yesterday. Opdivo and Yervoy are two of the most important blockbusters in the group–the former is expected to generate $6.5bn, the latter $1.2bn, and the companies’ sales volume will increase up to $10.3bn for Opdivo and $2.2bn for Yervoy in 2023.
(Sources: BMS, WSJ)