Firsts for AbbVie and BeOne

The Andrometa-PDAC-288 trial of AbbVie’s telisotuzumab adizutecan won’t be the first pivotal one for this anti-cMet ADC, but it will be the first to test it in pancreatic cancer. The study, just listed on clinicaltrials.gov, includes a phase 2 portion, to determine the optimal dose of teliso-A plus Folfox chemo, before this combo is compared against Folfirinox in a phase 3 stage. It follows the start of three earlier pivotal trials of teliso-A, in colorectal and lung cancers; the colorectal one, Andrometa-CRC, mandates cMet positivity, but no such requirement is evident in the enrolment criteria for Andrometa-PDAC-288. It’s also noteworthy that AbbVie’s first cMet-directed ADC, Emrelis, wasn’t tested specifically in pancreatic cancer, so the company really is trying to break new ground with teliso-A, whose payload is a topoisomerase 1 inhibitor, rather than MMAE. Elsewhere, other newly initiated pivotal studies include one of BeOne’s CDK4 inhibitor BGB-43395 in first-line HER2-negative breast cancer. That will be this project’s first phase 3 trial, but its design merely confirms what BeOne spelled out in February, with a Femara combo going head to head against physician’s choice CDK4/6 inhibitor plus Femara.

Selected new phase 3 trials

Source: OncologyPipeline.