Skip to content Skip to footer

Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026

Shots: Innate Pharma to present interim P-II (MATISSE) data (n=40) for IPH5201 at AACR Annual Meeting 2026, highlighting early efficacy in resectable NSCLC IPH5201 (anti-CD39) combined with durvalumab and chemotherapy showed promising pathological complete response (pCR) rates of 35.7% (PD-L1 ≥1%) and 50% (PD-L1 ≥50%) The study continues enrollment in PD-L1–positive pts., supporting further evaluation…

Read more

EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors

Shots: EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer Preclinical data showed robust anti-tumor activity across…

Read more

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

Read more

Gilead to Acquire Tubulis for ~$5B

Shots: Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26 Acquisition will expand…

Read more

Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: Revolution Medicines has started treatment in global P-III (RASolute 303) trial assessing daraxonrasib (PO) as monotx. & in combination with CT for the treatment of pts with previously untreated metastatic PDAC, irrespective of tumor RAS genotype The trial will assess PFS & OS as 1EP, while the key 2EPs include additional measures of antitumor…

Read more

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

Read more

Boehringer Ingelheim

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%…

Read more

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,…

Read more