August 17, 2022
Sanofi discontinuing amcenestrant trials in breast cancer
Sanofi has announced that it will stop the AMEERA-5 trial, a Phase 3 trial to determine the efficacy of amcenestrant plus palbociclib versus letrozole plus palbociclib in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative breast cancer.
The announcement came after the recommendation by the Independent Data Monitoring Committee, as amcenestrant plus palbociclib did not meet the prespecified boundary to continue the treatment. Sanofi stated that the patients on amcenestrant arm would be moved to palbociclib or another standard of care per the physician's choice.
Sanofi will also discontinue AMEERA-6, a Phase 3 trial evaluating amcenestrant versus tamoxifen in hormone-positive early breast-cancer patients.
August 5, 2022
Enhertu received FDA's nod for HER2-low breast cancer.
AstraZeneca's Enhertu (trastuzumab-deruxtecan) received FDA approval for unresectable or metastatic HER2-low breast cancer. This is the first therapy approved for HER2-low breast cancer.
The approval was based on the Phase-3 DESTINY-Breast04, which recruited 557 patients with unresectable or metastatic HER2-low breast cancer. The majority of the patients were HR+ (494), while others were HR-ve (63 patients). The risk of death was reduced by 50% in patients on Enhertu compared to patients on physician's choice of chemotherapy. The median progression-free survival was 9.9 months versus 5.1 months in patients on chemotherapy. Median overall survival was 23.4 months versus 16.8 months in patients on chemotherapy.
The company announced that the safety profile was consistent with the previous studies, and no new safety issues were observed.
Jan 17, 2022
AstraZeneca's and Daiichi Sankyo's Enhertu received priority status for HER-2 positive breast cancer with prior treatment
AstraZeneca and Daiichi Sankyo announced that the US FDA had accepted the supplemental Biologics Licence Application (sBLA) of Enhertu (trastuzumab deruxtecan) to treat patient HER-2 positive breast cancer who were previously treated with anti-HER2-regimen. The application has also received a priority review.
Enhertu is a HER2-directed antibody-drug conjugate (ADC). It reduced the risk of disease progress or death by 72% versus trastuzumab emtansine.
The sBLA is based on the Phase DESTINY-Breast03 trial. Patients who were previously treated with trastuzumab and a taxane for HER2-positive unresectable and/or metastatic breast cancer were included in the trial. The risk of disease progression or death is reduced by 72% compared to T-DM1. After one year of treatment, 94.1% were alive in the Enhertu arm compared to 85.9% in the T-DM1 arm. The objective response rate was 79.7% in the Enhertu arm versus 34.2% in the T-DM1 arm.
The drug is in different phases of development for gastric, lung, and colorectal cancer.
Gilead's Trodelvy approved for TNBC in Europe; provides a new option for 3L patients
Approval is based on Phase 3 ASCENT Study
Trodelvy showed improvement in the overall survival versus physician's choice of chemotherapy
Trodelvy (sacituzumab govitecan), a Trop-2-directed antibody-drug conjugate, is approved for treating triple-negative breast cancer patients. Trodelvy is indicated for patients who received two prior lines of therapy, one of which is indicated for advanced disease.
The approval is based on the Phase 3 ASCENT Study; Trodelvy demonstrated improvement in the overall survival versus chemotherapy. The risk of death was reduced by 49%; the overall survival was 11.8 months in the Trodelvy arm versus 6.9 months in patients on chemotherapy. The median progression survival improved to 4.8 months from 1.7 months (observed in physician's choice of chemotherapy).
Trodelvy was previously approved in Australia, Canada, Great Britain, Switzerland, and the United States for TNBC.
Merck's Keytruda was approved in Europe for certain patients with TNBC
European Commission has approved Keytruda in combination with chemotherapy in patients with triple-negative breast cancer. The drug is approved for a locally recurrent unresectable or metastatic tumor, express PD L1, and patients who have not received prior chemotherapy.
The drug was approved based on Phase 3 KEYNOTE-355 Study, in which Keytruda demonstrated statistically significant improvement in overall survival. This is the first breast cancer indication of Keytruda approved within Europe.
The approval is based on the Phase 3 KEYNOTE-355 trial; Keytruda, combined with chemotherapy, reduced the risk of death by 27% versus chemotherapy, progression-free survival increased by 34%. The median overall survival was 23 months in Keytruda plus chemotherapy combination versus 16.1 months in the chemotherapy alone. The median progression-free survival was 9.7 months versus 5.6 months in the chemotherapy alone.