The approval for this population is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32% (HR=0.68 [95% CI, 0.56-0.84]; p=0.0001), and progression-free survival (PFS), reducing the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.50-0.72]; p<0.0001), versus chemotherapy (investigator's choice of doxorubicin or paclitaxel). LENVIMA plus KEYTRUDA also demonstrated statistically significant improvement in objective response rate (ORR), with an ORR of 30% (95% CI, 26-36) versus 15% (95% CI, 12-19) for patients who received investigator's choice of doxorubicin or paclitaxel, in addition to a complete response rate of 5% for KEYTRUDA plus LENVIMA versus 3% for doxorubicin or paclitaxel and a partial response rate of 25% versus 13%, respectively.
Adverse reactions, some of which can be serious or fatal, may occur with LENVIMA, including hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, renal failure or impairment, proteinuria, diarrhea, fistula formation and gastrointestinal perforation, QT interval prolongation, hypocalcemia, reversible posterior leukoencephalopathy syndrome, hemorrhagic events, impairment of thyroid stimulating hormone suppression/thyroid dysfunction, impaired wound healing and osteonecrosis of the jaw. Based on the type and/or severity of the adverse reaction, LENVIMA may be interrupted, reduced and/or discontinued. Based on its mechanism of action and data from animal reproduction studies, LENVIMA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune- mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman.
"With a five-year survival rate of just 17%, 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," said Dr.
"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," said Dr.
"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," said Dr.
LENVIMA plus KEYTRUDA was previously approved under the
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