Akeso

Roivant acquires mosliciguat from Bayer for pulmonary hypertension; Viridian's thyroid eye disease treatment succeeds in Phase 3; Verily alums launch Highlander Health for clinical research optimization; House passes BIOSECURE Act restricting business with Chinese biotechs; Candid Therapeutics raises $370M for bispecific antibody therapies; Merck's Keytruda faces potential competition from Akeso's ivonescimab; Penn's gene therapy ATSN-101 shows promise for rare blindness.

Summit Therapeutics' ivonescimab reduced lung cancer progression or death risk by 49% compared to Keytruda in Phase III HARMONi-2 study, extending progression-free survival to 11 months vs. 6 months for Keytruda. The study involved 398 PD-L1-positive, advanced NSCLC patients in China, with ivonescimab showing higher severe side effects.

Akeso's stock surged after announcing promising lung cancer treatment results, outperforming Merck's Keytruda in a phase III trial. Ivonescimab showed increased progression-free survival and is pending approval in China, with potential for significant commercial success.

Akeso's PD-1/VEGF bispecific antibody ivonescimab showed significant results in a Phase II study for perioperative treatment of resectable NSCLC, with higher pCR and MPR rates when combined with chemotherapy. Ivonescimab, a global first-in-class immunotherapy drug, is being developed for multiple cancer indications and has met primary endpoints in Phase III studies, with several ongoing and planned clinical trials.

Ivonescimab showed superior PFS, ORR, and DCR vs. pembrolizumab in 1L PD-L1+ advanced NSCLC, with a PFS HR of 0.51 (P<0.0001) and mPFS of 11.14 months. Ivonescimab demonstrated significant benefits across PD-L1 expression, histology, and refractory subgroups, with an acceptable safety profile. HARMONi-7, a phase III trial, is planned for 2025.

Ivonescimab reduced risk of disease progression or death by 49% compared to pembrolizumab in first-line PD-L1 positive advanced NSCLC, with median PFS of 11.14 months vs 5.82 months. Benefits observed across subgroups, including PD-L1 high and low expression, and a comparable safety profile to pembrolizumab. Summit plans to initiate HARMONi-7, a Phase III trial in first-line PD-L1 high advanced NSCLC, in early 2025, and additional Phase II data in other solid tumors will be presented at ESMO 2024.

Akeso's PD-1/VEGF bispecific antibody ivonescimab showed significant Phase II results for perioperative treatment of resectable NSCLC at WCLC 2024. Ivonescimab, either as monotherapy or combined with chemotherapy, demonstrated high rates of pathological complete response (pCR) and major pathological response (MPR). Safety profile was manageable, with no TRAEs causing surgery cancellations or delays.

Summit Therapeutics' experimental therapy, ivonescimab, outperformed Merck's Keytruda in a late-stage lung cancer trial, reducing tumor progression risk by 49%.