May 31 (Reuters) - Gilead Sciences' ( GILD ) Trodelvy
failed to improve survival for patients with advanced bladder
cancer and only modestly extended the lives of previously
treated patients with late-stage lung cancer in a pair of
clinical trials, raising questions about growth prospects for
the medicine.
Trodelvy has accelerated U.S. approval for treating advanced
urothelial cancer, but Gilead on Thursday said a large trial
failed to confirm that the drug improved survival.
The study also linked Trodelvy to a higher number of deaths
compared to chemotherapy due to side effects including
infection.
On Friday, trial data presented at the American Society of
Clinical Oncology meeting in Chicago showed that Trodelvy
improved survival by just 1.3 months more than chemotherapy for
patients with advanced lung cancer, a difference that was not
statistically significant.
The company in January said that the non-small cell lung
cancer (NSCLC) trial had failed to meet its main goal.
"We believe that Gilead's Trodelvy will likely lose its
FDA-labeled indication for metastatic urothelial carcinoma, or
bladder cancer," Leerink analyst Daina Graybosch said in a
research note on Friday.
The bladder indication is estimated to account for about 10%
of Trodelvy sales, which totaled just over $1 billion in 2023.
Gilead's shares were down 1% at $63.20 on Nasdaq.
Trodelvy, an antibody-drug conjugate, is currently approved
in the U.S. for patients with two specific types of advanced
breast cancer and bladder cancer.
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 remain cautious on the potential for Gilead to get
Trodelvy on the market in lung cancer based on this study," RBC
Capital Markets analyst Brian Abrahams said in a note on Friday.
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 ( MRK )
immunotherapy Keytruda as an initial treatment for
patients with NSCLC, the most common lung cancer.
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, Bilal Piperdi, Gilead's vice president of
clinical oncology, said.