CHICAGO — Researchers on Friday afternoon pulled back the curtain on Gilead’s previously announced Phase 3 failure in certain forms of non-small cell lung cancer.
Gilead’s TROP2 antibody-drug conjugate Trodelvy is already approved in certain breast and bladder cancers. With the EVOKE-01 trial, the company had hoped it could expand into the lung cancer market as well. But it revealed in January that the drug had failed to significantly extend survival in second-line, metastatic, non-small cell lung cancer.
On Friday at the American Society of Clinical Oncology meeting, researchers detailed the data behind the miss on overall survival. The ADC drug showed a 16% reduction in risk of death compared to the chemotherapy docetaxel. Median overall survival was 11.1 months for patients on Trodelvy versus 9.8 months for patients on docetaxel, but with a one-sided p-value of 0.0534 — meaning the study didn’t hit statistical significance.
Unfortunately for Gilead, the failure isn’t the only recent blow to the drug. On Thursday, the company announced that Trodelvy failed a Phase 3 study in urothelial cancer, where it had an accelerated approval. Gilead acquired the drug in 2020 with its approximately $21 billion deal for Immunomedics. Earlier this year, it took a $2.4 billion impairment charge related to the deal.
Despite all that, the company sees some signs of hope. The data shared Friday showed that overall survival was greater in patients whose tumors didn’t respond to their last anti-PD(L)1-containing treatment, Gilead said. In that group, the median OS was 11.8 months on Trodelvy versus 8.3 months on docetaxel. That pre-specified subgroup comprised about two-thirds of the trial population.
Patients on Trodelvy had fewer grade 3 or worse adverse events and had fewer discontinuations from toxicities as compared to those on docetaxel, Gilead said. Those on Trodelvy did have more diarrhea, though.
Andrew Dickinson“These data, including the meaningful benefit observed in the sub-group of patients, are encouraging and warrants further investigation as these patients have a great unmet need,” Luis Paz-Ares, head of medical oncology service at Hospital Universitario 12 de Octubre in Madrid, said in a press release.
Gilead has previously said it could possibly conduct additional trials to look at narrower groups of patients.
“We may have to run another study in that patient population, but it’s going to take a while for us to work through all the data, talk to KOLs — but that’s a big opportunity in the second line,” Gilead CFO Andrew Dickinson said at an investor conference earlier this month, according to a transcript from AlphaSense. “Even if you’re talking about roughly half of the second-line in non-small cell lung cancer, it’s a really sizable opportunity.”
Gilead medical chief Merdad Parsey said in a Friday release that the company will “look forward to further investigating how these data may positively impact patients in the second-line setting.”
Trodelvy brought in $1.1 billion in sales last year.