Gilead Sciences announced Monday morning that Trodelvy is the first TROP-2-targeted ADC to demonstrate statistically significant and “clinically meaningful” overall survival results from a second interim analysis of a Phase 3 study in patients with HR+/HER2 metastatic breast cancer who have received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
The announcement surprised Wall Street analysts after Gilead revealed less than stellar OS results after first interim analysis at ASCO in June. But now Gilead said it had submitted an sBLA to the FDA for this new breast cancer indication, but it also said it won’t be presenting the actual OS data from the second interim analysis before an unidentified upcoming medical conference.
“These survival results from the TROPiCS-02 trial are important to the breast cancer community, and we are encouraged by the potential this could have to help patients who otherwise have limited alternatives,” said Merdad Parsey, CMO of Gilead, in a statement. “We look forward to discussing these results with global health authorities as previously treated patients with HR+/HER2 metastatic disease 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, accounting for approximately 70% of all new cases, or nearly 400,000 diagnoses, worldwide each year. But nearly 1 in 3 cases of early-stage breast cancer will develop metastases, and in patients with HR+/HER2 metastatic disease, the five-year relative survival rate is 30%, according to Gilead.
Analysts at SVB Securities added, “We expect the FDA to clear Trodelvy for HR+/HER2-mBC, but we need to see OS data to assess its competitive profile versus AZN’s Enhertu (OP, Berens). .”
RBC Capital Markets said in an investor note that most investors wrote off Trodelvy’s results in this indication after PFS data came in “positive but of uncertain clinical significance in March”, adding today:
This morning’s announcement that TROPiCS-02 demonstrated statistically significant and reportedly clinically meaningful OS benefits in a second interim analysis of the study of oncology drug Trodelvy in an important metastatic breast cancer indication undertaken by GILD is a surprise win for das company, as We believe that the market has largely written off the drug in this indication.
The OS at the first interim analysis was 13.9 months for Trodelvy, compared with 12.3 months for chemotherapy, RBC analysts also noted, adding that the difference “is probably just below the bar of clinical significance at this point.” lay”.
Trodelvy’s 2021 sales totaled $380 million for Gilead as the company said it had continued uptake of the approved treatment for the second-line treatment of metastatic triple-negative breast cancer in the US and Europe, as well as for the second-line treatment of metastatic urothelial cancer in the US.
Since then, sales have soared in 2022, which is welcome news for the company after Gilead took a $2.7 billion writedown on Trodelvy last quarter after another vague key statement was hot on its heels.
The pharmaceutical company drew savage criticism from analysts back in March when it revealed Trodelvy had met its primary endpoint of progression-free survival in late-stage metastatic HR+/HER2 breast cancer, but didn’t share the hard data.