Amgen (AMGN.US) Reports Increased Hepatotoxicity with Lumakras (Sotorasib) in Combination with Immune Checkpoint Inhibitors

According to the SmartCom APP, the Phase I data disclosed by Amgen (AMGN.US) last Sunday showed that the combination of the company's newly approved cancer drug Lumakras (sotorasib) with immunotherapy led to a higher incidence of severe liver side effects.

Data shows that in 2021, the U.S. Food and Drug Administration (FDA) approved the targeted anticancer drug Lumakras, which is a KRAS G12C inhibitor. Lumakras is the first KRAS-targeted therapy approved after nearly 40 years of research, and it is also the first and only targeted therapy approved for treating patients with locally advanced or metastatic NSCLC carrying the KRAS G12C mutation.

It is reported that the immunotherapies involved in this study are Pembrolizumab, developed by Merck (MRK.US), and Atezolizumab from Roche. For the combination therapy, 29% (17/58) of patients showed an objective response rate, indicating a reduction in tumor size; among the 17 patients confirmed to have responded, 5 patients had tumors that continued to respond to the treatment for more than 10 months, while 8 patients remained responsive.

Notably, Amgen pointed out that compared to previous data on Lumakras monotherapy, the combination of Lumakras and immunotherapy led to a higher incidence of grade 3-4 treatment-related adverse events (TRAEs), primarily due to elevated liver enzymes. Amgen also noted that patients who had received Lumakras prior to initiating combination therapy experienced lower rates of discontinuation and grade 3-4 TRAEs, and nearly all grade 3-4 TRAEs were resolved.

Dr. Bob T. Li, an oncologist and cancer researcher at the Caitlin Cancer Research Center, stated: "In fact, we observed a median duration of response of 17.9 months for patients receiving Lumakras as a lead-in to combination therapy, along with a lower incidence of adverse events, which provides a basis for our ongoing research in the first-line setting."