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Jump to Key Points Oct 6 (Reuters) - ArriVent BioPharma said on Tuesday its oral therapy to treat patients with a rare type of lung cancer did not significantly delay disease progression in a late-stage trial, sending its shares plunging nearly 60% in morning trading.
The therapy, firmonertinib, was tested in previously untreated patients with advanced non-small cell lung cancer (NSCLC) and a genetic alteration called EGFR exon 20 insertion mutation, which can fuel cancer growth.
The mutation occurs in roughly 0.5% to 1% of all NSCLC cases. NSCLC accounts for about 85% of all lung cancer cases.
In the trial, a 240-milligram dose of ArriVent's therapy extended median progression-free survival to 11 months versus 9.5 months with chemotherapy, an assessment by independent reviewers showed.
- Firmonertinib failed to meaningfully improve PFS in EGFR exon 20+ advanced NSCLC.
- Median PFS: 11 mo vs 9.5 mo with chemotherapy.
- Trial enrolled previously untreated advanced NSCLC with EGFR exon 20 insertion mutation.
- Control arm outperformed expected PFS; firmonertinib aligned with estimates.
- No new safety signals; PACC mutation trial continues.
CEO Bing Yao said the improvement in progression-free survival - a measure of time patients lived without the disease worsening or spreading - was not "meaningful."
"These disappointing results are not what we hoped for, particularly for the patients ... who urgently need more effective treatment options."
The company said it was evaluating the full dataset to determine the most appropriate development path for firmonertinib and that no new safety signals were identified in the trial.
The trial appears to have failed mainly because the control arm outperformed expectations, delivering 9.5 months of progression-free survival versus the estimated 7.5 to 8 months, while firmonertinib's 11 months was in line with the expected 9 to 11 months, said BTIG analyst Jeet Mukherjee.
Firmonertinib is also being tested in a late-stage trial for patients with NSCLC whose tumors contain uncommon EGFR PACC mutations.
"The result is a meaningful setback for the exon20 opportunity, however, the PACC program has clinical support," said Clear Street analyst Kaveri Pohlman.
The therapy is approved in China for NSCLC patients with certain mutations.
(Reporting by Christy Santhosh in Bengaluru; Editing by Devika Syamnath, Leroy Leo and Shinjini Ganguli)
