Ridhi Rastogi
Shots:
Exact Sciences has launched Oncodetect to detect MRD across multiple solid tumors, with its efficacy supported by strong clinical validation, incl. ~5yrs. of follow-up data from the Alpha-CORRECT study
Addiitonally, clinical & analytical validation studies across multiple solid tumors are underway, supported by strategic partnerships for multi-cancer evidence generation
Oncodetect test provides clear “Detected”…
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Novocure has reported CE Mark approval of Optune Lua for mNSCLC adults progressed on Pt-based regimen based on P-III (LUNAR) trial assessing the treatment vs PD-1/PD-L1 inhibitors/docetaxel alone; launch in Germany is expected in coming wks.
Trial showed improved OS (1EP), with an mOS of 13.2 vs 9.9mos. with treatment vs PD-1/PD-L1 inhibitors/docetaxel, 18.5…
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China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
Preclinical studies of K1, K2, & their combination showed…
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DAAN Biotherapeutics & GC Cell have entered into an exclusive technology transfer agreement for tumor antigen-specific antibody sequence
As per the agreement, DAAN has granted GC Cell exclusive rights to use its antibody sequence, which targets a protein highly overexpressed in major solid tumors, for research & development of CAR-T & CAR-NK therapies
Financial terms of…
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Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157)
Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…
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MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8)
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…
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VelaVigo Bio has granted Ollin Biosciences an exclusive license to develop, manufacture & commercialize VBS-102 worldwide, except Greater China, where VelaVigo will maintain its rights
As per the deal, VelaVigo will receive an upfront payment along with development, regulatory, & commercial milestones in cash & equity, making an aggregate of ~$440M, plus tiered royalties…
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The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regions
Study A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…