• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer. • IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer. • Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC. • Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.

• Merck halted the Phase 3 KeyVibe-008 trial after an independent review showed the vibostolimab/pembrolizumab combination with chemotherapy did not meet futility criteria for overall survival in ES-SCLC. • Patients receiving the vibostolimab and pembrolizumab fixed-dose combination experienced a higher rate of adverse events and immune-related adverse events compared to the control arm. • The trial evaluated vibostolimab, an anti-TIGIT antibody, combined with pembrolizumab (KEYTRUDA®), an anti-PD-1 therapy, plus chemotherapy versus atezolizumab plus chemotherapy as a first-line treatment. • Merck is currently notifying study investigators to stop treatment with the vibostolimab/pembrolizumab combination and offer patients the option to switch to atezolizumab.

• Daiichi Sankyo and Merck have expanded their existing partnership to include MK-6070, an investigational DLL3-targeting T-cell engager, with Merck receiving $170 million upfront in the agreement. • MK-6070 targets delta-like ligand 3 (DLL3), which is highly expressed in small cell lung cancer and neuroendocrine tumors, and has received FDA Orphan Drug Designation for SCLC treatment. • The companies plan to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in patients with small cell lung cancer, addressing an aggressive cancer with significant unmet treatment needs.

• Daiichi Sankyo and Merck have initiated the IDeate-Lung02 Phase 3 trial to evaluate ifinatamab deruxtecan (I-DXd) versus chemotherapy in relapsed small cell lung cancer (SCLC). • The trial will assess the efficacy and safety of I-DXd, a potential first-in-class B7-H3 directed antibody-drug conjugate, in patients who have progressed after one prior line of platinum-based chemotherapy. • The primary endpoints of the study are objective response rate (ORR) and overall survival, with secondary endpoints including progression-free survival and duration of response. • Approximately 460 patients across multiple continents will be enrolled in the IDeate-Lung02 trial, with the aim of addressing the unmet need for effective treatments in relapsed SCLC.

• Merck will pay Daiichi Sankyo $4 billion upfront plus $1.5 billion in continuation payments, with potential additional milestone payments reaching a total of $22 billion. • The collaboration focuses on three investigational antibody-drug conjugates: patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd), targeting multiple solid tumors. • Patritumab deruxtecan has received Breakthrough Therapy Designation for EGFR-mutated non-small cell lung cancer, with a biologics license application planned by March 2024.