- A relatively new immunotherapy from GSK matched the world’s best-selling cancer drug in shrinking tumors of lung cancer patients.
- The mid-stage study compared GSK’s Jemperli with Merck’s Keytruda in patients also receiving chemotherapy for metastatic non-squamous non-small cell lung cancer (NSCLC). The trial was positive, GSK said Wednesday, without giving detailed results. The study wasn’t designed to show superiority, but rather that patients had similar outcomes on either regimen.
- An approval for lung cancer patients would expand the label for Jemperli, which first won Food and Drug Administration clearance in April 2021 for women with endometrial cancer that had a specific genetic error. In August 2021, the FDA also approved the drug to treat a broader group of recurrent or advanced solid tumors classified as mismatch repair-deficient.
GSK has big plans for Jemperli, which to date ranks as a minor product. Jemperli had sales of 4 million pounds ($4.5 million) in the second quarter. Merck’s Keytruda generated $5.3 billion in the same period.
The new research supports the British drugmaker’s ambition to make Jemperli “the backbone” of its immuno-oncology development program, according to Hesham Abdullah, global head of oncology development at GSK. Full results from the PERLA study, including for the secondary endpoint of progression-free survival, will be presented at a scientific conference in the future, GSK said.
The trial includes 243 patients and is the largest global head-to-head comparison of drugs known as PD-1 inhibitors in this patient group, GSK said. The class of medicines target a protein called PD-1 to boost the body’s immune response against cancer cells. Besides Keytruda, others in the group include Bristol Myers Squibb’s Opdivo and Sanofi’s Libtayo.
GSK is also studying Jemperli in combination with a drug called cobolimab, which targets a different protein called TIM-3. That trial of 750 NSCLC patients, dubbed COSTAR, will now advance into Phase 3. In addition, researchers are evaluating Jemperli for patients with ovarian cancer and various advanced solid tumors and metastatic cancers.
Jemperli has potential for use both as a monotherapy and a combination therapy, Abdullah said in the company’s release. While many efforts to use immunotherapies in combination with other drugs have come up short, Bristol Myers recently found success with a treatment called Opdualag. The FDA cleared the combination therapy in March.