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Boehringer Ingelheim
NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…
3 days ago

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NEWS

Partner Therapeutics Reports P-II (eNRGy) Post-Hoc Results on Zenocutuzumab for NRG1+ NSCLC

Shots: Partner Therapeutics has reported post-hoc analysis from the eNRGy study assessing zenocutuzumab (marketed as Bizengri in the US) in pts with advanced NRG1+ NSCLC In 27 pts with NRG1+ NSCLC treated with zenocutuzumab (≥3 doses) beyond radiographic progression, 81% had oligoprogression & 19% diffuse progression, extending median exposure to ~10 vs ~7mos. pre-progression. Additionally,…
February 23, 2026

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NEWS

CStone Receives the US FDA IND Clearance to Initiate P-II Trial of CS2009 in Advanced Solid Tumors

Shots: The US FDA has granted IND Clearance to initiate P-II trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in pts with advanced solid tumors CS2009 is being evaluated in a P-II trial (currently enrolling) across Australia & China, spanning 15 cohorts to evaluate monotx. & combination regimens in 9 solid tumors, incl. NSCLC, colorectal cancer, TNBC,…
February 17, 2026

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Eli lilly
NEWS

Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

Shots: Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…
February 17, 2026

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Akesobio
NEWS

Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer

Shots: The Chinese NMPA has granted BTD to ivonescimab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Ivonescimab is being assessed in the fully-enrolled P-III (AK112-309/HARMONi-GI1) in combination with CT for the 1L treatment of advanced BTC The P-Ib/II trial data presented at ASCO 2024 showed ivonescimab plus CT showed an…
February 6, 2026

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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

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NEWS

D3 Bio Receives the US FDA IND Clearance to Initiate P-I trial of D3S-003 & P-II Combination Study of Elisrasib (D3S-001) with D3S-002

Shots: FDA has granted IND clearance to initiate D3S-003 a P-I, and a P-II combination study of D3S-001 (elisrasib), a next-gen KRAS G12C inhibitor, with D3S-002, an oral ERK1/2 inhibitor The P-II trial will evaluate the D3S-001 + D3S-002 combination in KRAS G12C–mutant NSCLC patients who have progressed on prior KRAS G12C therapies to assess…
January 19, 2026

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NEWS

ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC

Shots: ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…
January 15, 2026

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Daiichi Sankyo
NEWS

Daiichi Sankyo Initiates P-III (TROPIONLung17) Trial of Datroway in Nonsquamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient in the P-III (TROPIONLung17) trial of Datroway for TROP2-NMR–positive LA/M nonsq. NSCLC without actionable genomic alterations previously treated with immunotherapy (IT) & Pt-based CT Trial will evaluate Datroway (6mg/kg) vs docetaxel in above-mentioned pts (n=~400) across Asia, EU & North America, assessing PFS & OS as dual…
January 14, 2026

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