The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.
Gilead is withdrawing Trodelvy from the market in bladder cancer after a confirmatory study did not meet its primary endpoint. The antibody-drug conjugate (ADC), which will remain on the market in other indications, is a pillar of Gilead’s cancer portfolio.
Trodelvy was approved for the indication under accelerated review in 2021, with a requirement that the company conduct a confirmatory trial to obtain a full approval.
Results for that trial, called TROPiCS-04, were announced in June, showing that Trodelvy failed to improve overall survival in patients with metastatic bladder cancer. Gilead noted a higher number of deaths from adverse events in the Trodelvy arm than the group that received a treatment of the physician’s choice. The company said at the time that the data would be analyzed with next steps communicated at a later date.
Gilead has now decided to take the drug off the market for the indication. Trodelvy’s traditional approvals in different types of advanced breast cancer are not affected by the withdrawal in bladder cancer.
The accelerated approval in bladder cancer was granted on Phase II data from the single-arm TROPHY-U-01 study. Gilead conducted the TROPiCS-04 to confirm a clinical benefit. Gilead intends to report full results from that trial at an upcoming medical meeting.
Trodelvy was the first Trop-2-directed ADC approved, according to Gilead. The company is testing it across a range of tumor types, including lung and gynecological cancers, but the outcomes, like the TROPiCS-04 study, have not been ideal so far.
The therapy failed to improve overall survival in the Phase III EVOKE-1 trial of patients with previously treated metastatic non-small cell lung cancer (NSCLC) in January. Gilead later pointed to a subgroup of patients who didn’t respond to previous PD-1/L1 treatment who saw a benefit.
Nevertheless, demand for Trodelvy helped drive Gilead’s oncology program to a 37% year-over-year improvement in product sales, with $2.9 billion recorded for full-year 2023, according to a year-end 2023 earnings report. Trodelvy booked $1.1 billion of that—a 56% increase year-over-year. The rest of the cancer earnings came from Gilead’s cell therapy portfolio.
More recently, Gilead CEO Daniel O’Day reported that Trodelvy clocked a 23% increase year-over-year for the second quarter to $320 million. CFO Andrew Dickinson clarified on the second quarter earnings call that bladder cancer accounted for about 10% of Trodelvy’s sales.
O’Day expressed confidence in the breast cancer indication while the lung and bladder cancer indications were under review. Gilead is awaiting results from a handful of Phase III trials that could support moving Trodelvy into earlier lines of treatment for breast cancer. The company faces fierce competition from AstraZeneca’s drug datopotamab deruxtecan, which is partnered with ADC powerhouse Daiichi Sankyo.
Gilead will present third quarter earnings on November 6.
