Novartis Reports Positive Long-Term Clinical Results for Kisqali; AstraZeneca Advances Two Oncology Therapies with FDA Actions

According to announcements from various companies and the FDA's official website, Novartis' CDK4/6 inhibitor Kisqali has shown positive long-term clinical results, AstraZeneca's PD-L1 inhibitor combination has received priority review designation from the FDA, and AstraZeneca/Daiichi Sankyo's ADC has received FDA approval for extended indications.

Novartis: Positive Long-term Clinical Results for CDK4/6 Inhibitor

Novartis announced that its CDK4/6 inhibitor Kisqali (ribociclib), when used in combination with fulvestrant as a first-line therapy, extended the overall survival of postmenopausal HR+/HER2- advanced or metastatic breast cancer patients by nearly 16 months compared to fulvestrant alone in a Phase 3 clinical trial. The press release noted that Kisqali is the first CDK4/6 inhibitor-fulvestrant combination to demonstrate an overall survival benefit in this first-line treatment setting.

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow cancer progression by inhibiting two cyclin-dependent kinases 4 and 6 (CDK4/6). When these proteins are overactivated, they can cause cancer cells to grow and divide too rapidly.

In this latest analysis, at a median follow-up time of 5 years, the median overall survival for patients in the Kisqali combination therapy group reached 67.6 months, compared to 51.8 months in the fulvestrant group. The Kisqali combination therapy reduced the risk of death by 33%. Moreover, as a first-line treatment, Kisqali delayed the need for subsequent chemotherapy by more than a year and a half.

AstraZeneca: PD-L1 Inhibitor Combination Granted FDA Priority Review

AstraZeneca announced that the FDA has granted priority review status to the supplemental Biologics License Application (sBLA) for the anti-PD-L1 antibody durvalumab (Imfinzi), to be used in combination with standard chemotherapy for the treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).

Durvalumab is a humanized monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80, countering tumor immune escape, and relieving the suppression of anti-cancer immune responses.

This sBLA is based on the interim analysis results of the phase 3 clinical trial TOPAZ-1. The trial results showed that the combination of durvalumab and chemotherapy reduced the risk of death by 20% compared to chemotherapy alone (HR=0.80, 95% CI, 0.66-0.97, p=0.021). In the group treated with durvalumab combination therapy, 25% of patients were still alive after two years, compared to 10% in the chemotherapy group.

Moreover, the combination therapy of durvalumab reduced the risk of disease progression or death by 25% (HR=0.75, 95% CI, 0.64-0.89, p=0.001).

AstraZeneca/Daiichi Sankyo ADC Receives FDA Approval

The FDA's official website shows that the FDA has approved the expanded indication for Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo, for the treatment of patients with unresectable or metastatic HER2-positive breast cancer.

Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform, consisting of a humanized monoclonal antibody targeting HER2 connected to a topoisomerase 1 inhibitor payload via a cleavable tetrapeptide linker.

This approval was based on data from the pivotal phase 3 clinical trial DESTINY-Breast03. In the trial, compared to the active control group, Enhertu reduced the risk of disease progression or death by 72% ([HR]=0.28; 95% CI: 0.22-0.37) in patients with HER2-positive unresectable and/or metastatic breast cancer who had previously received trastuzumab and taxane treatment. According to the assessment by Blinded Independent Central Review (BICR), the median progression-free survival (PFS) for patients treated with Enhertu had not yet been reached (95% CI: 18.5-NE), while it was 6.8 months (95% CI: 5.6-8.2) in the active control group.

Editor: Qijin

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