Sotorasib receives accelerated approval from the FDA for KRAS G12C mutant NSCLC

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August 2021: The FDA granted accelerated approval to sotorasib (LumakrasTM, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, as determined by an FDA-approved test.

As companion diagnostics for Lumakras, the FDA has approved the QIAGEN therascreen® KRAS RGQ PCR kit (tissue) and the Guardant360® CDx (plasma). The tumour tissue should be evaluated if no mutation is found in the plasma sample.

The approval was based on CodeBreaK 100, a multicenter, single-arm, open label clinical study (NCT03600883) that included patients with KRAS G12C mutations who had locally progressed or metastatic NSCLC. The efficacy of the drug was tested in 124 patients whose disease had progressed on or after at least one previous systemic therapy. Sotorasib 960 mg orally once a day was given to patients until disease progression or intolerable toxicity.

The primary effectiveness outcomes were the objective response rate (ORR) according to RECIST 1.1, as determined by a blinded independent central review, and response length. With a median response time of 10 months (range 1.3+, 11.1), the ORR was 36 percent (95 percent CI: 28 percent, 45 percent).

Diarrhea, musculoskeletal pain, nausea, exhaustion, hepatotoxicity, and cough were the most prevalent side effects (20%). Decreased lymphocytes, decreased haemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium were the most prevalent laboratory abnormalities (25 percent).

Sotorasib is taken once a day, with or without food, at a dose of 960 mg.

The 960 mg dose was approved based on available clinical evidence as well as pharmacokinetic and pharmacodynamic simulations that supported the amount. The FDA is demanding a postmarketing trial as part of the evaluation for this accelerated approval to see if a lower dose will have a similar therapeutic effect.

 

Reference : https://www.fda.gov/

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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

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