AbbVie and RemeGen’s bispecific goes pivotal

AbbVie was a relative latecomer to the PD-(L)1 x VEGF field, recently licensing RemeGen’s RC148, but this asset will soon go into pivotal development.

A new listing on clinicaltrials.gov details a Chinese phase 2/3 study in first-line colorectal cancer, adding to a Chinese phase 3 in first-line NSCLC that went up in February. And, according to RemeGen’s JP Morgan presentation, Chinese and US studies in second-line NSCLC are coming – with AbbVie presumably leading the latter.

First-line NSCLC

The first-line NSCLC space is already crowded, with recent entrants including two other Chinese groups, Sinocelltech and Huabo.

RemeGen’s phase 3 study, due to start at the end of March, will test RC148 plus chemo, versus BeOne’s Tevimbra plus chemo, in patients with first-line squamous disease. The protocol requires a PD-L1 test, but doesn’t appear to be mandate PD-L1 expression; the primary endpoint is progression-free survival.

The PD-(L)1 x VEGF leaders, Summit/Akeso’s ivonescimab and Bristol Myers Squibb/BioNTech’s pumitamig, are already in various first-line NSCLC trials, in both PD-L1 expressers and all comers. And Summit’s US Harmoni-3 trial is set to yield data in squamous all comers this year.

Despite being behind, RemeGen is claiming potential best-in-class efficacy, highlighting a 67% ORR with RC148 20mg/kg plus chemo in a phase 1/2 trial. This result came in the tough-to-treat post-PD-(L)1 plus chemo population, so it could bode well for first-line use – but RemeGen still has some way to go to catch up.

First-line colorectal

First-line colorectal cancer could be less crowded, at least for now, although the big players already have trials under way here, too. As well as ivonescimab and pumitamig, this also includes Pfizer’s PF-08634404, licensed from 3SBio. 

RemeGen’s study in microsatellite-stable disease, due to start in April, will be a phase 2/3, with the phase 2 portion testing two different doses of RC148 plus chemo, and the phase 3 part pitting the combo against Avastin plus chemo. RemeGen doesn't appear to have released any data yet with RC148 in colorectal cancer. 

Bristol’s Rosetta-CRC-203 trial of pumitamig is also a phase 2/3, but Summit’s Harmoni-GI3 of ivonescimab and Pfizer’s Symbiotic-GI-03 study of PF-08634404 are straight phase 3s. In any case, these are global studies, while RemeGen's will take place in China. AbbVie’s next move with this asset will be eagerly awaited.

Pivotal trials of RC148

Note: *ph2/3 trial. Source: OncologyPipeline & clinicaltrials.gov.