Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: 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…

ByRidhi Rastogi2 days ago

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BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

BeOne has reported topline P-III (MANGROVE) trial results on Brukinsa (Zanubrutinib; 160mg, PO, BID) + rituximab vs bendamustine + rituximab in 510 adults with previously untreated mantle cell lymphoma The trial met its 1EP of improved PFS as assessed by IRC, leading to a 43% reduction in the risk of progression or death; OS (2EP) was immature…

ByRidhi Rastogi3 days ago

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AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Shots: The topline P-III (EPCORE DLBCL-4) trial results assessed epcoritamab + lenalidomide vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in adults with R/R DLBCL who received ≥1L prior of therapy Trial met its 1EP, significantly improving PFS & reducing the risk of disease progression or death by 60% (US censoring) & 56% (ex-US censoring). AbbVie…

ByRidhi Rastogi4 days ago

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Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

ByRidhi Rastogi4 days ago

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Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

Shots: Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the…

ByRidhi RastogiJune 25, 2026

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F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

Shots: F2G & Shionogi have reported the topline P-III (OASIS) trial data assessing olorofim (PO) vs AmBisome followed by SoC in 225 pts with invasive aspergillosis whose infection is either refractory to or unsuitable for azole therapy Trial met its 1EP of non-inferiority, with a rate of all-cause mortality of 23.8% vs 24.3% at Day 42,…

ByRidhi RastogiJune 18, 2026

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Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Shots: Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…

ByRidhi RastogiJune 17, 2026

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Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

Shots: The Takeda's P-III (FirstLight & RadiantLight) trial assessed oveporexton (BID) in NT1 pts over 12wks, where FirstLight randomized 168 pts to 3 arms (2mg, 1mg & PBO), while RadiantLight randomized 105 pts to two arms (2mg & PBO); regulatory filing is under review in the US (priority review), China & Japan At Wk. 12,…

ByRidhi RastogiJune 16, 2026

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Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Shots: Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…

ByRidhi RastogiJune 15, 2026

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Eli Lilly Reports P-I (AJX-101) Trial Data on AJ1-11095 in Previously Treated Myelofibrosis

Shots: Eli Lilly reported the P-I (AJX-101) trial, assessing AJ1-11095 (25, 50, 75, 100, & 125mg, QD) in 23 pts with myelofibrosis who have been failed by a type I JAK2 inhibitor, at EHA 2026 AJ1-11095 achieved a 70% SVR35 & 70% TSS50 rate at Wk. 12, with driver mutation VAF reductions observed in 21 pts;…

ByRidhi RastogiJune 15, 2026

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

AbbVie and Genmab Report P-III (EPCORE DLBCL-4) Trial Data Results on Epcoritamab + Lenalidomide for R/R DLBCL

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety

F2G and Shionogi Report Topline P-III (OASIS) Trial Results on Olorofim in Invasive Aspergillosis

Edgewise Therapeutics Reports the P-II (CIRRUS-HCM) Trial Data on EDG-7500 for Obstructive and Nonobstructive Hypertrophic Cardiomyopathy

Takeda Presents P-III (FirstLight & RadiantLight) Trial Data on Oveporexton for Narcolepsy Type 1 (NT1) at SLEEP 2026

Akeso Reports First Patient Enrolment in P-Ib/II Trial of AK138D1 ± Ivonescimab for Breast Cancer

Eli Lilly Reports P-I (AJX-101) Trial Data on AJ1-11095 in Previously Treated Myelofibrosis

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