Promised pivotal head-to-head studies materialise

ArriVent and Lyell both recently promised to test their lead projects head-to-head against similarly acting therapies, and now these phase 3 studies have appeared on the clinicaltrials.gov registry. The Alpacca trial of ArriVent's firmonertinib will pit this EGFR inhibitor against AstraZeneca's Tagrisso or Boehringer Ingelheim's Gilotrif in first-line NSCLC with PACC mutations, with co-primary endpoints of ORR (for accelerated approval) and PFS (for subsequent full approval). Neither Tagrisso nor Gilotrif is approved specifically for PACC-mutated lung cancer, but both are used in this setting on the basis of US NCCN guidelines. Meanwhile, Lyell is taking the anti-CD19 x CD20 Car-T therapy rondecabtagene autoleucel into the Pinacle-H2H study against Gilead's Yescarta or Bristol Myers Squibb's Breyanzi in second-line large B-cell lymphoma patients who have received chemo and Rituxan but not Car-T therapy. This measures event-free survival as primary endpoint, and targets a less advanced disease setting than the uncontrolled Pinacle trial, which tests ORR and should be the first to read out.

Selected recently disclosed phase 3 trials

Source: OncologyPipeline.