Gilead Sciences said Monday morning that Trodelvy is the first TROP-2-directed ADC to show statistically significant and “clinically meaningful” results, in the second interim of a phase 3 trial in patients with HR+/HER2- metastatic breast cancer. overall existence from the analysis. Pre-endocrine therapy, CDK4/6 inhibitors and two to four lines of chemo.
Announcement stuns Wall St. analysts after Gilead’s unveiling less than stellar The result of the OS after the first interim analysis at the ASCO in June. But now, Gilead said it has submitted an SBLA to the FDA for this new breast cancer indication, but added that it will not present the actual OS data from the second interim analysis until an undisclosed upcoming medical conference.
“These survival results from the Tropics-02 study are important to the breast cancer community and we are encouraged by its ability to help patients who otherwise have limited options,” Gilead’s CMO Mardad Parsi said in a statement. “We look forward to discussing these results with global health authorities, as pre-treated HR+/HER2-metastatic disease patients currently have limited treatment options and poor quality of life.”
Hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common type of breast cancer and accounts for about 70% of all new cases, or about 400,000 diagnoses worldwide each year. Is. But according to Gilead, about 1 in 3 cases of early-stage breast cancer become metastatic, and among patients with HR+/HER2-metastatic disease, the five-year relative survival rate is 30%.
Analysts at SVB Securities said that “we expect the FDA to approve Trodelvi for HR+/HER2-MBC, but we need to look at OS data to assess its competitive profile versus AZN (OP, Berens) Enhartu.” needed.”
RBC Capital Markets said in an investor note that after the PFS data came “with positive but uncertain clinical significance back in March”, most investors had written off Trodelavi’s results in this indication:
Announcement this morning that TROPiCS-02 showed a statistically significant, and reportedly clinically meaningful, OS benefit in a second interim analysis GILD has taken in a trial of the oncology drug Trodelvy in a major metastatic breast cancer indication, the company said. As we believe, the market wrote off most of the drug in this indication.
The OS in the first interim analysis was 13.9 months for Trodelvi, compared to 12.3 months for chemo, also noted by RBC analysts, noting that the difference “likely to bar for clinical significance at that point”. was less.”
Trodelvi sales totaled $380 million for Gilead in 2021, as the company said it has approved treatments for second-line metastatic triple-negative breast cancer in the US and Europe, as well as second-line metastatic urothelial cancer in the US. Seen steady growth. ,
Sales are up in 2022, which is welcome news for the company as Gilead took a $2.7 billion writedown last quarter on the heels of another vaguely conclusive readout for Trodelvy.
The pharma company received harsh reviews from analysts in March after it learned that Trodelavi met its primary endpoint of progression-free survival in late-line metastatic HR+/HER2-breast cancer, but did not share hard data. .