HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

Shots: HUTCHMED has completed pts enrollment in P-II trial assessing savolitinib for G/GEJ adenocarcinoma pts (n=64) with MET amplification to evaluate ORR per IRC (1EP) & 2EPs incl. PFS & AE incidence; HUTCHMED plans to file for potential NMPA’s Approval in late 2025 Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…

ByRidhi RastogiApril 22, 2025

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Alumis and ACELYRIN Revise Merger Agreement, Boosting ACELYRIN Stake

Shots: Alumis and ACELYRIN have amended their 2025 merger agreement, which originally granted ACELYRIN stockholders 0.4274 Alumis shares/share, giving them a 45% stake in the combined company As per the amendment, ACELYRIN stockholders will receive 0.4814 Alumis shares/share, allowing them to own 48% of the combined entity on a fully diluted basis; closing expected in Q2'25…

ByRidhi RastogiApril 22, 2025

NEWS

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Shots: The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Trial showed improved PFS (1EP); OS (2EP) was immature but showed…

ByRidhi RastogiApril 22, 2025

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LIFE SCIENCES | DAILY NEWS | APRIL 22, 2025 | PHARMASHOTS

ByRidhi RastogiApril 22, 2025

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Exact Sciences launches Oncodetect for Molecular Residual Disease (MRD) Detection

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”…

ByRidhi RastogiApril 22, 2025

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Novocure Reports CE Mark Approval of Optune Lua for Metastatic NSCLC (mNSCLC)

Shots: 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…

ByRidhi RastogiApril 22, 2025

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HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots: 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…

ByRidhi RastogiApril 21, 2025

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GC Cell Partners with DAAN Biotherapeutics for Tumor Antigen-Specific Antibody Sequence

Shots: 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…

ByRidhi RastogiApril 21, 2025

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Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: 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…

ByRidhi RastogiApril 21, 2025

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GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: 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…

ByRidhi RastogiApril 21, 2025

Ridhi Rastogi

HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

Alumis and ACELYRIN Revise Merger Agreement, Boosting ACELYRIN Stake

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

LIFE SCIENCES | DAILY NEWS | APRIL 22, 2025 | PHARMASHOTS

Exact Sciences launches Oncodetect for Molecular Residual Disease (MRD) Detection

Novocure Reports CE Mark Approval of Optune Lua for Metastatic NSCLC (mNSCLC)

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

GC Cell Partners with DAAN Biotherapeutics for Tumor Antigen-Specific Antibody Sequence

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

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