GlaxoSmithKline’s drug for the treatment of endometrial cancer with specific genetic characteristics is now available for solid tumors with the same mutation, regardless of where the tumor is located in the body.This Expand FDA approval For GSK drug Jemperli, it positions immunotherapy in a broader market, but it still has a long way to go to catch up with Merck’s blockbuster drug Keytruda.
Four months later, the regulator nodded Jemperli is first approved for the treatment of endometrial cancerAs with the decision, the wider use of the drug approved is for patients who have received chemotherapy before but whose cancer is still progressing.
The problematic genetic change, mismatch repair defect (dMMR), affects the cell’s ability to repair DNA mutations that cause cancer. This mutation is common in colorectal cancer and Jemperli’s approved endometrial cancer indications. According to the National Cancer Institute, dMMR mutations are also present in breast, prostate, bladder, and thyroid cancers. Jemperli is an immunotherapy called a checkpoint inhibitor. Like Keytruda, GSK drugs can block PD-1, a “checkpoint” protein on immune cells that prevents them from attacking tumors. Blocking this protein allows immune cells to recognize and track cancer cells.
The FDA’s latest approval for Jemperli is based on the results of an open-label Phase 1 study that evaluated 209 patients with recurrent or advanced solid tumors with dMMR mutations. The patient received a 500 mg intravenous infusion of the drug every three weeks for six weeks, and then a 1,000 mg dose every six weeks until the cancer progressed or the toxicity of the drug became intolerable.
The main goal of the study is to measure the overall response rate to treatment, which is evaluated by changes in tumor size. The FDA stated that the GlaxoSmithKline drug shrank tumors in 41.6% of patients. Among these responders, 9.1% had a complete response, while 32.5% showed a partial response. The median duration of response was 34.7 months. For 95.4% of patients, the response to treatment was six months or longer.
The most common adverse reactions reported in clinical trials are fatigue, weakness, anemia, diarrhea, and nausea. Like other immunotherapies, including Keytruda, the drug’s label warns that immune-mediated adverse reactions can be serious or even fatal.
Keytruda is approved for the treatment of a range of cancers, and it has become Merck’s best-selling product, with revenue of $14.4 billion in 2020. In 2019, the FDA Grant Keytruda the first approval to treat cancer based on specific gene signatures, No matter where the tumor is found in the body. Jemperli is one of three products in GSK’s oncology product portfolio. According to GlaxoSmithKline’s financial report, the drug generated £1 million in revenue in the second quarter of this year.
Using Jemperli requires testing to confirm dMMR mutations. While approving the drug for solid tumors, the FDA also approved Roche companion diagnostics to test genetic characteristics. The FDA’s decision to expand the use of Jemperli is an accelerated approval that requires less standard review data than the agency requires and makes faster decisions. Retention of approval will require additional research by GlaxoSmithKline to confirm that patients are benefiting from treatment.
GlaxoSmithKline acquired Tesaro for US$5.1 billion, adding Jemperli to its product line 2019. Jemperli’s other tests are in progress and may support expand Use of drugs. GSK is testing the drug as an early treatment for endometrial cancer. The company is also evaluating the combination of the drug with other therapies for potential applications in other types of cancer.
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