#China #Hong Kong #Akeso #Ivonescimab #HARMONi-A

Significant Advancements in NSCLC Treatment with Ivonescimab

In a groundbreaking moment for lung cancer treatment, the results of the HARMONi-A study were recently presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in National Harbor, Maryland, USA. These findings represent a pivotal development in the use of ivonescimab, an innovative immunotherapy drug, which has been combined with chemotherapy for patients suffering from EGFR-mutant non-squamous non-small cell lung cancer (nsq-NSCLC) post progression on EGFR-TKI therapy.

Key Findings

The HARMONi-A study is notable for being the first Phase III clinical trial to demonstrate statistically significant improvements in both Overall Survival (OS) and Progression-Free Survival (PFS) in patients with EGFR-TKI-resistant nsq-NSCLC. In the analysis conducted with a median follow-up of 32.5 months, patients receiving the ivonescimab combination therapy exhibited a median OS of 16.8 months, compared to just 14.1 months for those treated with chemotherapy alone. This translates to an OS hazard ratio (HR) of 0.74, indicating a 26% reduction in the risk of mortality compared to the control group (P=0.019).

What makes these results especially compelling is the consistent benefit observed across all subgroups. The ivonescimab regimen yielded favorable OS outcomes regardless of whether patients had brain metastases or different types of EGFR mutations (19Del and L858R). For instance, those with brain metastases showed an OS HR of 0.61, while patients without brain metastases had an OS HR of 0.77. Moreover, patients with various EGFR mutations also experienced significantly improved survival times.

Safety Profile

In addition to its efficacy, the safety profile of the ivonescimab combination regimen is reassuring. Throughout the 32.5-month follow-up, no new safety signals emerged, and the rate of treatment-related adverse events was comparable to that of the control group, suggesting that ivonescimab could offer a safe option for patients requiring treatment.

Regulatory Progress and Future Implications

Since receiving approval from the China National Medical Products Administration in May 2024, ivonescimab has been included in China’s National Reimbursement Drug List as of November 2024, enhancing the accessibility of this therapy for patients in need. Furthermore, Akeso, the company behind ivonescimab, is collaborating with Summit Therapeutics to seek regulatory approval from the U.S. FDA; a Biologics License Application (BLA) submission is anticipated in the fourth quarter of 2025, signifying a significant step towards broader global access for this innovative treatment.

The clinical outcomes from the HARMONi-A study are substantial, especially considering the historical difficulties faced by cancer immunotherapies in demonstrating similar advancements in this challenging patient population. Previous trials involving different therapies, such as PD-1 inhibitors combined with chemotherapy, have often failed to achieve such marked improvements in outcomes, thus positioning ivonescimab as a potentially transformative option in the therapeutic landscape of EGFR-mutant nsq-NSCLC.

A New Hope for Patients

The final OS analysis from the HARMONi-A study underscores ivonescimab's potential to significantly enhance survival in patients who have previously faced limited options after progressing on standard therapies. As more details emerge following this crucial presentation at SITC 2025, the expectations around ivonescimab continue to grow, offering new hope to patients and stakeholders alike.

In conclusion, the HARMONi-A study findings highlight a promising future for ivonescimab in treating EGFR-mutated lung cancer. With its strong OS and PFS results, alongside an encouraging safety profile, this therapy could soon reshape the standard of care for patients with advanced nsq-NSCLC.