Skip to content Skip to footer
Subscribe Now
NEWS

Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…
August 5, 2026

Read more

Akesobio
NEWS

Akeso Reports First Patient Dosing in P-Ib/II Study of AK138D1 + Ivonescimab in NSCLC

Shots: Akeso has dosed the first patient in the P-Ib/II (AK138D1-201) trial assessing AK138D1, as monotx. or in combination with ivonescimab for advanced NSCLC The study will evaluate the regimen across multiple settings in advanced NSCLC, incl. 1L treatment, treatment after EGFR-TKI resistance, & treatment after immuno-CT resistance AK138D1 is a HER3-targeted ADC comprising a…
July 28, 2026

Read more

Akesobio
NEWS

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…
June 15, 2026

Read more

NEWS

Summit Therapeutics Reports the US FDA’s BLA Acceptance for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has accepted BLA of ivonescimab + CT for the treatment of EGFR-mutated locally advanced or metastatic non-squamous NSCLC post-TKI therapy (PDUFA: Nov 14, 2026) BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC who…
January 30, 2026

Read more

NEWS

Summit Therapeutics Reports the US FDA’s BLA Submission for Ivonescimab to Treat EGFRm Non-Squamous NSCLC

Shots: The US FDA has received BLA of ivonescimab + CT for ≥2L treatment of pts with EGFR-mutated locally advanced or metastatic non-squamous NSCLC; decision is expected by Q4’26 BLA was supported by P-III (HARMONi) trial assessing ivonescimab + Pt-doublet CT vs PBO + Pt-doublet CT in pts with EGFR-mutated, locally advanced or metastatic NSCLC…
January 13, 2026

Read more

summit therapeutics &pfizer
NEWS

Summit Therapeutics Partners with Pfizer to Assess Ivonescimab in Combination with Pfizer’s ADCs for Various Solid Tumor Settings

Shots: Summit has entered into a clinical trial collaboration with Pfizer to assess safety & anti-tumor activity of ivonescimab with multiple Pfizer’s vedotin ADCs in solid tumors; trials are expected to initiate in mid-2025 As per the deal, Summit will supply ivonescimab for proposed trials & Pfizer will handle operations, with both firms jointly…
February 25, 2025

Read more

Akesobio
NEWS

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

Shots: Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308)  study of Ivonescimab + CT  for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China) The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…
February 21, 2025

Read more

Load more