Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

Shots: Chinese NMPA has approved ivonescimab + CT for the 1L treatment of pts with advanced squamous NSCLC (sqNSCLC), based on the global P-III (HARMONi-6) trial The trial, sponsored by Akeso, assessed ivonescimab + CT vs Tevimbra + CT to treat Chinese pts with 1L sqNSCLC irrespective of PD-L1 expression, showing improved OS & PFS;…

ByRidhi Rastogi7 hours ago

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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…

ByRidhi RastogiAugust 5, 2026

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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…

ByRidhi RastogiJuly 28, 2026

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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…

ByRidhi RastogiJune 15, 2026

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Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

ByRidhi RastogiJune 12, 2026

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Akeso Presents the P-III (HARMONi-6) Trial Data on Ivonescimab + CT in 1L Squamous NSCLC at ASCO 2026

Shots: The Akeso's global P-III (HARMONi-6/AK112-306) trial assessed ivonescimab + CT vs Tevimbra + CT to treat pts (n=532) with 1L sqNSCLC, meeting its 2EP of improved OS As of Feb 27, 2026 (mFU: 21.36mos.), ivonescimab + CT reduced the death risk by 34%(mOS: 27.9 vs 23.7mos.), with 12 and 24mos. OS rate of 78.9%…

ByRidhi RastogiJune 1, 2026

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Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Shots: Akeso has reported the P-II (COMPASSION-26) trial results assessing cadonilimab + CT as the 1L treatment of advanced pancreatic ductal adenocarcinoma (PDAC) As of Oct 20, 2025 (mFU of >2yrs.), trial showed robust & durable survival benefits, with mPFS of 11.1mos. & mOS of >23mos., showing 12 & 24mos. OS rate of 91.7% &…

ByRidhi RastogiApril 21, 2026

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Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots: Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…

ByRidhi RastogiApril 7, 2026

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Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Shots: The P-II (COMPASSION-03/AK104-201) trial assessed cadonilimab in pts with recurrent or metastatic CC who have failed prior Pt-based CT, showing mOS of 17.5mos. in pts regardless of PD-L1 expression, with18 & 24mos. OS rates of 47.8% & 40.9%, respectively Updated data with 26.5mos. mFU showed that among 99 efficacy-evaluable pts achieving CR, mOS & PFS…

ByRidhi RastogiMarch 5, 2026

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Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Shots: The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…

ByRidhi RastogiFebruary 11, 2026

Summit and Akeso Reports NMPA Approval for Ivonescimab + CT for 1L Squamous NSCLC

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

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

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

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Akeso Presents the P-III (HARMONi-6) Trial Data on Ivonescimab + CT in 1L Squamous NSCLC at ASCO 2026

Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

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