ArriVent BioPharma’s Phase 3 lung cancer trial was clouded by stronger-than-expected data for patients receiving chemotherapy, prompting analysts to pivot focus to a late-stage test of the tyrosine kinase inhibitor in a different type of lung cancer and to the biotech’s antibody-drug conjugate pipeline.
ArriVent BioPharma’s investigational tyrosine kinase inhibitor failed to significantly improve progression free survival rates in a Phase 3 lung cancer trial, sending the biotech’s stock spiraling.
ArriVent’s Phase 3 study, called FURVENT, enrolled nearly 400 patients with advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (Ex20ins). The open-label study assessed ArriVent’s most advanced asset firmonertinib, an EGFR TKI designed to penetrate the brain.
Firmonertinib, which ArriVent shares with Shanghai-based Allist Pharmaceuticals, failed to meet FURVENT’s main goal, recording a median progression free survival (PFS) of 11 months compared to 9.5 months for patients on chemotherapy, as measured by blinded independent central review (BICR). The finding was not statistically significant, according to ArriVent’s Tuesday release.
Truist analysts view the miss as largely fueled by a stronger-than-expected PFS seen in the control group receiving chemotherapy. The cohort’s median 9.5-month survival rate was up from an expectation of seven months, according to the firm.
“With these results, we see the path forward in Ex20ins as uncertain as mgmt reviews the full dataset and potential development options,” Truist wrote in a Tuesday note to investors. The analysts therefore removed Ex20ins NSCLC from its valuation of ArriVent, lowering its expected price target from $45 per share to $18.
Analyst sentiment aligned with the market’s response to the data, with ArriVent’s share price plummeting nearly 50%, from $28.46 to $12.09 at market close Tuesday.
ArriVent pointed to clinical benefit as measured by secondary endpoints, like the investigator-assessed 11.1 month PFS for firmonertinib compared to 7.1 months for chemotherapy.
The difference in investigator-assessed findings compared to BICR underscored “a meaningful discordance in control-arm assessment,” Truist wrote.
No new safety signals were identified in the trial, with findings consistent with previous firmonertinib studies.
Truist is now turning its attention to ALPACCA, an ongoing Phase 3 study of firmonertinib for patients with EGFR PACC mutant NSCLC. The firm sees limited readthrough from FURVENT to ALPACCA, believing that this week’s findings still support the therapy’s potential to produce a competitive efficacy profile against the Tagrisso/Gilotrif control.
ArriVent launched in June 2021 with $90 million and ex-China rights to furmonertinib from Allist. The drug had received conditional approval from China regulators earlier that year for patients with advanced NSCLC and a confirmed EGFR T790M mutation that had progressed during or after EGFR TKI therapy.
Truist believes the FURVENT outcome “resets the story with a cleaner setup” for ArriVent’s antibody-drug conjugate ARR-217, which is slated as a late-breaker at this year’s European Society for Medical Oncology in Spain toward the end of October. The asset is being developed in partnership with China’s Lepu Biopharma for colorectal cancer and gastrointestinal cancers. The Phase 1 data in colorectal cancer could help build the case for ARR-217 to rebuild pipeline value.
“With FURVENT now behind us, we see ARR-217’s late-breaking Ph.1 data at ESMO as a cleaner opportunity to reshape conversation around AVBP’s ADC pipeline,” Truist wrote on Tuesday.
