Shots:
Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%)
IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…
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Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib) for the treatment of pts with lung cancer; closing is expected in H2’26
As per the deal, AstraZeneca will acquire worldwide rights to develop & commercialise Zegfrovy in exchange for $600M upfront, & ~$900M in development, regulatory & sales milestones, with tiered royalties…
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Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC
The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…
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Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026
The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT,…
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GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer
As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…
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Lilly's global P-III (LIBRETTO-432) trial assessed Retevmo (selpercatinib; 160mg, BID) vs PBO in 151 pts with early-stage (IB-IIIA) RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy
Trial met the 1EP, improving the EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of…
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The US FDA has granted BTD to Merck's calderasib (MK-1084) + Keytrudafor the 1L treatment of pts with advanced or metastatic NSCLC with KRAS G12C-mutation & expressing PD-L1 (TPS ≥1%)
Designation was supported by P-I (KANDLELIT-001) trial data showing calderasib monotx. (n=21) achieved a 38% ORR, calderasib + Keytruda (n=69) delivered an ORR of 77%, while…
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Junshi Biosciences has reported the final analysis from the P-III (NEOTORCH) trial assessing toripalimab + Pt-containing doublet CT vs PBO + CT as perioperative treatment in 501 pts with resectable stage II-III NSCLC pts
Trial improved EFS, with mEFS not reached vs 15.1mos. for CT alone, reducing risk of recurrence, progression, or death by 60%,…
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The NMPA has granted conditional approval to Hernexeos (zongertinib) for initial treatment of adults with unresectable, locally advanced, or metastatic NSCLC harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations
Approval was based on the data from a treatment-naïve cohort (N=74) of P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75.7% (10.8%…
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The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy
sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…

