On a wing and a prayer, Bristol takes GM1 pivotal

Undeterred by shortcomings in the phase 2 data it presented at ESMO, Bristol Myers Squibb is pressing ahead with a phase 3 study of its anti-fucosyl-GM1 MAb BMS-986012. As promised earlier the pivotal trial will test a combination with Opdivo in first-line SCLC against one of the two available standards of care, Tecentriq plus chemo. One new aspect, however, is that phase 3 will test a fixed-dose combo of BMS-986012 and nivolumab (coded BMS-986489), a recently unveiled listing on clinicaltrials.gov reveals. In a similar front-line SCLC setting, phase 2 data showed a marginal, exploratory OS benefit for BMS-986012 plus Opdivo, and no effect on PFS. This is a questionable precedent for moving into phase 3, given that efficacy tends to deteriorate in large, multicentre trials; in addition, the phase 2 study used a non-standard comparator of Opdivo plus chemo. The phase 3 trial measures OS as sole primary, and the median number to beat is 12.3 months, as recorded by Tecentriq plus chemo in Impower-133. Perhaps one factor driving Bristol’s enthusiasm is BMS-986012’s uniqueness: OncologyPipeline reveals no other fucosyl-GM1-directed projects in development.

First-line extensive-stage SCLC comparison

Source: OncologyPipeline.