Two Ivonescimab (PD-1/VEGF) Results including Phase 3 Monotherapy versus Pembrolizumab Monotherapy in First-Line Treatment for PD-L1 Positive NSCLC to Be Presented at WCLC 2024

On August 11, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") reported two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer ("WCLC24"), taking place in San Diego, USA from September 7-10, 2024 (Press release, Akeso Biopharma, AUG 11, 2024, View Source [SID1234645701]). Among these is a late-breaking Presidential Symposium presentation featuring results from the HARMONi-2/AK112-303 study, which evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS ≥1%).

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The late-breaking result of HARMONi-2/AK112-303 will be presented by Professor Zhou Caicun, the principal investigator of HARMONi-2 and director in the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University.

Presentations during WCLC 2024

Abstract Title

Presentation Details

Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: Primary Analysis of HARMONi-2

Session: PL02 Presidential Symposium 1 (LIVESTREAMED)

Form: Plenary oral

Presenter: Caicun Zhou, MD. Ph.D, China Shanghai Pulmonary Hospital

Abstract release time: embargoed until the presentation day

A Phase 2 Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer

Session: Perioperative Strategies 1—Early-Stage Non-Small Cell Lung Cancer

Sunday, September 8, 2024, 11:17 AM-11:27 AM

Form: Oral

Presenter: Xiaoliang Zhao, MD, China Tianjin Medical University Cancer Institute & Hospital

Abstract release time: August 14, 2024

Akeso will also participate as an exhibitor, actively engaging with professionals from diverse fields.

Milestones of ivonescimab:

May 2024:
Ivonescimab was granted marketing approval for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"), making it the world’s first approved PD-1/VEGF bi-specific antibody.

May 31:
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

June 01:
Interim result of the Phase III study of ivonescimab combined with platinum-doublet chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR-TKIs treatment (HARMONi-A ), was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and the study was ranked as the top report on the TOP 10 list of lung cancer at ASCO (Free ASCO Whitepaper) by OncoAlert, an international cancer support organization. On the same day, the research findings were also published simultaneously in the JAMA journal.

July 25:
Akeso’s partner, Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit,") announced a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the purpose of accelerating the development in certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer.

July 29:
The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA). This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.

August 02:
The supplemental New Drug Application (sNDA) for ivonescimab monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic NSCLC was accepted by China NMPA with priority review.

About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.