At the ongoing American Society of Clinical Oncology (ASCO) Congress 2024, investigators revealed the Phase III HARMONi-A trial (NCT05184712) results of its PD-1/VEGF bispecific antibody ivonescimab, combined with pemetrexed and carboplatin chemotherapy in treating non-squamous, stage IIIB to IV, EGFR-mutated non-small cell lung cancer (NSCLC) patients who previously received any EGFR tyrosine kinase inhibitor (TKI). Compared to the chemotherapy control, ivonescimab plus chemotherapy demonstrated a superior overall response rate (ORR) of 50.6% (versus 35.
4%), in addition to an improved median progression-free survival (PFS) of 7.06 months (versus 4.8 months) at a median follow-up duration of 7.
89 months. Despite a positive trend, the overall survival (OS) data was immature at the time of the presentation. Still, Grade 3 or above treatment-emergent adverse events (TEAEs) had a higher occurrence in patients in the ivonescimab arm (61.
5% versus 49.1%). Outside of ASCO conference, the outcome of the Phase III HARMONi-2 trial (NCT05499390) was announced in a press release from Akeso on 30 May , where ivonescimab trumped MSD’s Keytruda (pembrolizumab) as a monotherapy in treating first-line, stage IIIB-IV, PD-L1 positive (tumor proportion score ≥1%) NSCLC patients.
The encouraging results of HARMONi-A and HARMONi-2 trials marked the second success of Akeso’s Tetrabody bispecific platform after the PD-1/CTLA-4 bispecific cadonilimab. The gold standard of business intelligence..
