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
Study | Active | Control | mOS in active arm |
---|---|---|---|
Tigos (ph3) | BMS-986489 (BMS-986012 + nivolumab FDC) + chemo | Tecentriq + chemo | TBC (primary endpoint) |
Ph2 | BMS-986012 + Opdivo + chemo | Opdivo + chemo | 15.6 months |
Impower-133 (ph3) | Tecentriq + chemo | Chemo | 12.3 months |
Source: OncologyPipeline.
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