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Pharma Tech Outlook | Tuesday, July 27, 2021
LENVIMA, a single-agent drug developed by Eisai Co., has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with endometrial cancer whose tumors have specific characteristics.
FREMONT, CA: Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, New Jersey, United States of America declare that the United States Food and Drug Administration (FDA) has approved the combination of LENVIMA, Eisai's orally available multiple receptor tyrosine kinase inhibitor, and KEYTRUDA, Merck & Co., Inc., Kenilworth, New Jersey, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
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The approval for this population is based on the pivotal Phase 3 Study 309/KEYNOTE-775 trial, which demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32 percent (HR=0.68 [95 percent CI, 0.56-0.84]; p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40 percent (HR=0.68 [95 percent CI, 0.56-0.84]; p=0.000 LENVIMA plus KEYTRUDA also demonstrated a statistically significant improvement in objective response rate (ORR), with an ORR of 30 percent (95 percent confidence interval [CI], 26-36) versus 15 percent (CI, 12-19) for patients treated with doxorubicin or paclitaxel at the investigator's discretion, in addition to a complete response rate of 5 percent for KEYTRUDA plus LENVIMA versus 3 percent for doxorubicin or paclitaxel.
"With a five-year survival rate of just 17 percent, women with advanced endometrial cancer who are not candidates for curative therapy, particularly those with disease progression following prior systemic therapy have limited treatment options," says Dr. Vicky Makker, principal investigator and medical oncologist, Memorial Sloan Kettering Cancer Center. "This approval is an important step forward in helping patients fight this difficult-to-treat malignancy, as physicians can now provide an option that may improve survival outcomes."
"When compared to the chemotherapies used in this trial, this combination treatment regimen was proven to extend the lives of certain patients diagnosed with previously treated, advanced endometrial cancer," says Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "Based on Phase 3 data, today's approval acts as the confirmatory trial to our previous accelerated approval of KEYTRUDA plus LENVIMA in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer."
"This FDA approval of LENVIMA plus KEYTRUDA for the treatment of patients with certain types of advanced endometrial cancer is an important step forward towards helping this patient community that has had limited treatment options," says Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "This marks a culmination of our relentless pursuit to address unmet needs of people with cancer, and we owe our deepest gratitude to those who participated in our Study 309/KEYNOTE-775 trial, their families and clinicians, and to our employees, whose collective commitment made this meaningful milestone possible."
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