Merck Launches Phase III Trial of MK-2870 (SKB264) Plus Keytruda vs. Keytruda Monotherapy in First-Line PD-L1 High NSCLC

On December 14, a Phase III clinical trial (study code: MK-2870-007) of MK-2870 (SKB264, sacituzumab tirumotecan) was registered on the ClinicalTrials.gov website. The trial aims to evaluate the efficacy and safety of MK-2870 in combination with Keytruda (pembrolizumab, trade name: Keytruda) compared to Keytruda monotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥50%.

The study plans to enroll 614 patients, with an expected start date of December 26, 2023, and completion by May 27, 2030. The primary endpoint of the study is overall survival (OS).

To date, MSD has initiated three Phase III clinical trials to explore the application potential of MK-2870 and evaluate its therapeutic effects in different types of tumors. The other two studies are:

• MK-2870-004 (n=556): Efficacy and safety of MK-2870 monotherapy compared with docetaxel or pemetrexed in previously treated patients with advanced or metastatic non-squamous NSCLC harboring EGFR mutations or other genetic mutations.

• MK-2870-005 (n=710): Efficacy and safety of MK-2870 monotherapy versus chemotherapy (doxorubicin + paclitaxel) in endometrial cancer patients previously treated with platinum-based chemotherapy and immunotherapy.

MK-2870 is an antibody-drug conjugate (ADC) targeting TROP2. It has been granted three Breakthrough Therapy Designations (BTD) for: ① locally advanced or metastatic triple-negative breast cancer (TNBC) that has failed at least two prior lines of therapy; ② locally advanced or metastatic EGFR-mutated NSCLC that has failed EGFR-TKI treatment; and ③ locally advanced or metastatic HR+/HER2- breast cancer that has previously received at least two lines of systemic chemotherapy.

Recently, an application for marketing authorization has been submitted to the National Medical Products Administration (NMPA) for MK-2870 (brand name: Jiatilai) intended for unresectable locally advanced or metastatic TNBC in patients who have previously received at least two systemic therapies (at least one of which was for advanced or metastatic stage).

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reproduce it, please leave a message to the WeChat Official Account's backend or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Exciting Preview

Online Live Streaming & Offline Salon