By Deena Beasley
(Reuters) – Gilead Sciences’ Trodelvy improved survival by 1.3 months more than chemotherapy in previously treated patients with advanced lung cancer in a late-stage trial, a difference that was not statistically significant, the company said on Friday.
Patients given Trodelvy lived for a median of 11.1 months, while those on chemotherapy lived for 9.8 months, Gilead said. The company in January said that the non-small cell lung cancer (NSCLC) trial had failed to meet its main goal of proving Trodelvy could extend survival over chemotherapy.
The full results, presented at the annual American Society of Clinical Oncology meeting in Chicago and published in the Journal of Clinical Oncology, show that Trodelvy reduced the risk of death by 16%, with similar improvement for harder-to-treat squamous and non-squamous types of NSCLC.
Trodelvy, which belongs to a class of treatments known as antibody drug conjugates, is currently approved in the U.S. for patients with two specific types of advanced breast cancer and bladder cancers.
Gilead said the 603-patient lung cancer trial showed a survival improvement of 3.5 months for patients given Trodelvy whose tumors had not responded to a last round of immunotherapy.
For patients whose lung cancer had responded to their last immunotherapy, overall survival was a month longer for the chemotherapy group.
“We think Trodelvy is a very active drug in lung cancer and also quite tolerable,” Bilal Piperdi, Gilead’s vice president of clinical oncology, said in an interview.
Serious side effects were reported by 67% of Trodelvy patients and 76% of chemotherapy patients. The most common side effects for Trodelvy were fatigue, diarrhea and hair loss.
Gilead is also studying Trodelvy in combination with Merck’s immunotherapy Keytruda as an initial treatment for NSCLC patients.
Results for a small subset of patients in one of those ongoing studies has shown they lived a median of 13.1 months before their cancer worsened. That is an improvement over the seven- to eight-month progression-free survival seen in Keytruda trials, Piperdi said.
(Reporting By Deena Beasley; Editing by Bill Berkrot)
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