Furmonertinib - (FURVENT)

May 11, 2026: ArriVent BioPharma, Inc. (NASDAQ: AVBP) reported Q1 2026 results and outlined upcoming oncology pipeline catalysts.

Firmonertinib (EGFR inhibitor; NSCLC): The company reiterated that topline monotherapy data from the global pivotal Phase 3 FURVENT trial (NCT05607550) in first-line EGFR exon 20 insertion mutant non-squamous locally advanced/metastatic NSCLC is projected in mid-2026. FURVENT compares firmonertinib 160 mg or 240 mg QD vs platinum/pemetrexed; primary endpoint is PFS by BICR (RECIST 1.1), with CNS endpoints in patients with baseline brain metastases. ArriVent also noted ongoing global enrollment in the pivotal Phase 3 ALPACCA study (NCT07185997) in first-line EGFR PACC-mutant NSCLC (firmonertinib 240 mg vs osimertinib or afatinib; co-primary endpoints ORR and PFS by BICR). Preclinical firmonertinib structural/crystal data were presented at AACR 2026. The release also notes partner Allist received China NMPA accelerated approval in Feb 2026 for second-line EGFR exon 20 insertion NSCLC after/intolerant to platinum chemo.

ADC pipeline:

• ARR-217 (MRG007; CDH17 ADC): FDA IND clearance; first patient dosed March 2026; Phase 1 dose escalation ongoing in GI malignancies. Milestone: complete escalation and initiate dose optimization in 2H 2026.
• ARR-002 (AV-P138-ADC; MUC16/NaPi2b dual-target tetravalent ADC): FDA IND cleared May 2026 for ovarian and endometrial cancers; first-in-human Phase 1 planned (safety/dosing/early efficacy). Milestone: dose first patient in 2H 2026. Preclinical tolerability/anti-tumor activity vs single-target/bivalent ADCs presented at AACR.

Financials: Cash/investments $326.4M as of March 31, 2026; runway expected into 4Q 2027. Net loss $43.3M for Q1 2026.