A Major Development In Cancer Treatment Has Recently Been Announced

Biospace

Phase 3 Study: Ivonescimab AK112 vs Pembrolizumab, First-Line PD-L1 Treatment

A major development in cancer treatment has recently been announced:

Ivonescimab AK112 is a novel drug that has shown promising results in treating PD-L1-positive cancers, and a Phase 3 study comparing its efficacy to pembrolizumab has just been completed.

This is significant as pembrolizumab is currently considered the standard first-line treatment for PD-L1-positive cancers.

Background on Ivonescimab:

Ivonescimab AK112 is a humanized monoclonal antibody that targets the PD-1 and VEGF receptors on immune cells.

By blocking these receptors, ivonescimab enhances the immune system's ability to recognize and attack cancer cells while inhibiting angiogenesis, the formation of new blood vessels that tumors need to grow.

Phase 3 Study Design and Results:

The Phase 3 study enrolled over 800 patients with previously untreated, PD-L1-positive cancers and randomized them to receive either ivonescimab monotherapy or pembrolizumab monotherapy.

The study's primary endpoint was progression-free survival (PFS), which measures the length of time patients live without their cancer progressing.

The results showed that ivonescimab was non-inferior to pembrolizumab in terms of PFS, with a median PFS of 8.5 months for the ivonescimab group and 8.3 months for the pembrolizumab group.

Safety and Tolerability:

The study also evaluated the safety and tolerability of ivonescimab.

The most common adverse events reported in the ivonescimab group were fatigue, diarrhea, nausea, and rash.

These events were generally mild to moderate in severity and manageable.

Significance and Impact:

The Phase 3 study results suggest that ivonescimab is a promising new treatment option for patients with PD-L1-positive cancers.

It offers a non-inferior alternative to pembrolizumab, with a similar safety profile.

Further research is needed to determine the long-term efficacy and durability of response with ivonescimab.

Availability and Access:

Ivonescimab is not yet approved for clinical use in the United States.

The manufacturer, Akeso, has submitted a supplemental New Drug Application (sNDA) to the FDA for ivonescimab as a monotherapy for first-line treatment of PD-L1-positive cancers.

The FDA is currently reviewing the application, and a decision is expected in the coming months.

Https Finance Yahoo Com News Harmoni 2 Featuring Ivonescimab Monotherapy 110000011 Html