China’s NMPA Accepts sBLA for Ivonescimab in First-Line PD-L1+ NSCLC

China’s Nationwide Medical Merchandise Administration (NMPA) has accepted a supplemental biologics license utility (sBLA) looking for the approval of ivonescimab (AK112; SMT112) monotherapy for the first-line remedy of sufferers with regionally superior or metastatic non–small cell lung most cancers (NSCLC) who’ve a PD-L1 tumor proportion rating (TPS) of a minimum of 1%.¹

The sBLA is supported by information from the section 3 HARMONi-2 trial (NCT05499390), which confirmed that remedy with ivonescimab led to a statistically important and clinically significant enchancment in progression-free survival (PFS) vs pembrolizumab (Keytruda) in sufferers with regionally superior or metastatic, PD-L1–optimistic NSCLC. A prespecified interim evaluation demonstrated that the PFS profit was noticed throughout varied subgroups, together with these with a PD-L1 TPS of 1% to 49%; these with a PD-L1 TPS of a minimum of 50%; these with squamous or nonsquamous histology; and people with different high-risk options.²

“As a researcher and clinician, we eagerly anticipate ivonescimab changing into the brand new commonplace remedy for first-line lung most cancers, offering a superior ‘chemotherapy-free’ possibility for sufferers,” Zhou Caicun, MD, PhD, principal investigator of the HARMONi-2 research and director of the Oncology Division at East Hospital Affiliated To Tongji College, in Shanghai, China, acknowledged in a information launch.1 “The success of the HARMONi-2 research underscores the immense worth of ivonescimab’s synergistic twin anti-tumor mechanism of ‘tumor immunotherapy plus anti-angiogenesis.’”

Ivonescimab is a novel, potential first-in-class investigational bispecific antibody directed at PD-1 and VEGF.

HARMONi-2 was a multicenter, randomized, managed trial that enrolled sufferers a minimum of 18 years of age with histologically or cytologically confirmed stage IIIB/C or IV NSCLC who had a optimistic PD-L1 expression on tumor tissue.Different key inclusion standards consisted of a life expectancy of a minimum of 3 months; an ECOG efficiency standing of 0 or 1; measurable illness per RECIST 1.1 standards; and ample organ perform.³

Prior systemic remedy for regionally superior or metastatic NSCLC was not allowed, and sufferers couldn’t have illness harboring EGFR mutations or ALK translocations. Different key exclusion standards included any histologically confirmed small cell carcinoma element; a analysis of immunodeficiency or remedy with systemic steroids inside 2 years of first research dose; main surgical procedure inside 30 days of enrollment; and recognized central nervous system metastases.

Eligible sufferers have been randomly assigned to obtain both intravenous (IV) ivonescimab at a specific dose or IV pembrolizumab at 200 mg as soon as each 3 weeks.

Impartial radiographic assessment committee (IRRC)–assessed PFS per RECIST 1.1 standards served because the trial’s major finish level. Secondary finish factors included total survival; IRRC- and investigator-assessed total response charge, length of response, illness management charge, and time to response; investigator-assessed PFS; and security.

Security information confirmed that ivonescimab was manageable, and its profile was per therapies supposed to inhibit PD-1 and VEGF.²

“We’re thrilled that ivonescimab has achieved a major milestone in first-line lung most cancers remedy shortly after its approval for second-line remedy,” Michelle Xia, PhD, founder, chairwoman, president, and chief govt officer of Akeso, added in a information launch.¹ “We sincerely thank all our colleagues at Akeso for his or her decade-long dedication and craftsmanship, the consultants for his or her meticulous contributions, and all of the individuals concerned within the initiatives.”

The section 3 HARMONi (NCT06396065) and HARMONi-3 (NCT05899608) trials are additionally investigating ivonescimab in sufferers with NSCLC. HARMONi is investigating ivonescimab plus chemotherapy vs placebo plus chemotherapy in sufferers with EGFR-mutated, regionally superior or metastatic nonsquamous NSCLC who skilled illness development after remedy with a third-generation EGFR TKI. HARMONi-3 is exploring ivonescimab plus chemotherapy vs pembrolizumab plus chemotherapy as first-line remedy for sufferers with metastatic squamous NSCLC.²

References

1. Akeso’s sBLA for ivonescimab in 1L remedy of PD-L1 optimistic NSCLC accepted by NMPA. Information launch. Akeso. July 29, 2024. Accessed July 29, 2024. https://www.prnewswire.com/news-releases/akesos-sbla-for-ivonescimab-in-1l-treatment-of-pd-l1-positive-nsclc-accepted-by-nmpa-302208466.html
2. Ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to-head, achieves statistically important superiority in PFS in first-line remedy of sufferers with PD-L1 optimistic NSCLC. Information launch. Akeso, Inc. Might 30, 2024. Accessed July 29, 2024. https://www.prnewswire.com/news-releases/ivonescimab-monotherapy-decisively-beats-pembrolizumab-monotherapy-head-to-head-achieves-statistically-significant-superiority-in-pfs-in-first-line-treatment-of-patients-with-pd-l1-positive-nsclc-302159842.html
3. AK112 in superior non-small cell lung most cancers. ClinicalTrials.gov. Up to date September 21, 2023. Accessed July 29, 2024. https://basic.clinicaltrials.gov/ct2/present/NCT05499390