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Merck & Co Inc (NYSE:MRK) and Eisai Co Ltd (OTC:ESALY) (OTC: ESALF) have provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating Keytuda plus Lenvima, in patients with certain types of metastatic non-small cell lung cancer.
The Phase 3 LEAP-006 trial evaluating Keytuda plus Lenvima in combination with Alimta (pemetrexed) and platinum-containing chemotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) versus Keytruda with pemetrexed and platinum-containing chemotherapy for metastatic, nonsquamous non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)- or c-ros oncogene 1 (ROS1)-directed therapies are not indicated.
The Phase 3 LEAP-008 trial evaluating Keytruda plus Lenvima versus docetaxel for metastatic NSCLC progressed on or after platinum-containing chemotherapy and one prior anti-PD-1/-L1 immunotherapy and have confirmation that EGFR-, ALK- or ROS1-directed therapies are not indicated, did not meet its dual primary endpoints of OS and PFS.
At the study's final analysis, there was no improvement in OS for patients treated with Keytuda plus Lenvima with chemotherapy compared to Keytruda with chemotherapy.
Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate, a key secondary endpoint.
In the LEAP-006 and LEAP-008 trials, the safety profiles of the Keytruda plus Lenvima-based treatment regimens were consistent with those observed in previously reported studies.
Keytruda plus Lenvima is approved in the U.S., the EU, Japan, and other countries for advanced renal cell carcinoma and certain types of advanced endometrial carcinoma.
In April, after disappointing data, Merck and Eisai discontinued the Phase 3 LEAP-003 trial of Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma.
Price Action: MRK shares are up 0.06% at $106.79 on the last check Friday.
