BMS’ Opdivo/Yervoy 1L maintenance therapy relevance to be clouded by Roche’s SOC-changing IMpower 133 results, experts say

27 Sep 2018

Bristol-Myers Squibb’s (NYSE:BMY) bid for Opdivo (nivolumab) and Yervoy (ipilimumab) as a maintenance therapy following chemotherapy in small cell lung cancer (SCLC) will likely be thwarted by the expected addition of Roche’s (SIX:ROG) Tecentriq (atezolizumab) to the first-line (1L) setting, experts said.

Analysts stated that since responses to 1L chemotherapy are not durable, even when they are high, a maintenance strategy for Opdivo/Yervoy could be the ideal entry point for the combination. Yet, experts this news service interviewed noted that the Phase III CheckMate 451 (NCT02538666) is not evaluating the combination after Tecentriq/chemotherapy but rather after chemotherapy alone, which will set back even positive results.

On 25 September, Roche’s stock moved up 1.5% after it released details at the World Conference on Lung Cancer (WCLC) from the previously announced positive Phase III IMpower 133 study (NCT02763579), which evaluated Tecentriq/chemotherapy as a 1L therapy in extensive-stage SCLC patients.

Prior to the full IMpower 133 results, one analyst hypothesized that the use of tumor-mutational burden (TMB) coupled with the magnitude of benefit seen in TMB-high SCLC patients in Bristol-Myers Squibb’s (BMS’) Phase II CheckMate 032 study (NCT01928394) could position BMS to compete effectively in 1L SCLC. However, interviewed experts were more skeptical given TMB-related data was restricted to a subset analysis, part of which was nonrandomized, adding that the need for TMB testing standardization persists.

CheckMate 451 results are expected in 2H, the company stated in its June corporate presentation. A BMS spokesperson declined to speculate on market impact due to competitor data. The company’s market cap is USD 100.5bn, while Roche's is CHF 204.2bn (USD 209bn).

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