Onco-Summaries: Daily Oncology Updates at a Glance
22/09/2026
US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results (Ref)
Compass Therapeutics provides regulatory update on feedback received from the US FDA regarding Tovecimig (DLL4 × VEGF-A bispecific antibody) for previously treated advanced biliary tract cancer
The US FDA has advised that an additional study demonstrating an overall survival (OS) benefit may be required before a Biologics License Application (BLA) can proceed
Compass disagrees that a new trial is necessary before BLA submission and believes the existing Phase 2/3 COMPANION-002 data, combined with the high unmet need in BTC, support moving forward. The company plans further discussions with the FDA while continuing BLA preparation efforts
Results from the Phase 2/3 COMPANION-002 trial demonstrated:
ORR of 18.0% versus 5.3% for paclitaxel alone (p=0.0228)
Median PFS of 4.7 months versus 2.6 months
56% reduction in risk of disease progression (HR=0.44; p<0.0001)
Although the study did not achieve a statistically significant OS benefit, the company attributes this to substantial patient crossover from the control arm to tovecimig treatment
Tovecimig has received FDA Fast Track and Orphan Drug designations
Thomas Schuetz, CEO, Compass: “While this is not the response we expected, we respect the FDA’s feedback and our priority is to work with the Agency to determine the best path forward to support our planned BLA submission and address this pressing unmet need. We remain confident that the COMPANION-002 findings, including the statistically significant improvements in PFS and ORR combined with subset analyses on survival, demonstrate clinically meaningful activity in patients with previously treated, advanced BTC.”
US FDA Conditionally Accepts LYRFIGTU™ Brand Name for Lirafugratinib (Ref)
Elevar Therapeutics announced that the FDA has conditionally accepted LYRFIGTU™ as the proposed brand name for lirafugratinib (FGFR2-targeted therapy) for cholangiocarcinoma
Conditional acceptance is a standard regulatory step and remains subject to final approval of the drug
Lirafugratinib is currently under FDA Priority Review for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements, with a PDUFA action date of September 25, 2026
The regulatory submission is supported by results from the ReFocus Phase 1/2 trial, which demonstrated a 46% confirmed objective response rate (ORR) and median duration of response (DoR) of 11.8 months
Elevar Therapeutics stated that it is preparing for a potential commercial launch pending FDA approval
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