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NEWS

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Shots: P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer P2 pts (n=880) received Keytruda (400mg, IV…
January 27, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 20, 2025 – January 24, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, DigiHealth, MedTech, Biosimilars, Animal Health & Biotech. Check out our full report below:         Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes  Read More: Novo Nordisk  Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat…
January 24, 2025

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NEWS

Rakuten Medical Commences Global P-III (ECLIPSE) Study of ASP-1929 Plus Keytruda as a 1L Treatment of Recurrent Head and Neck Cancer

Shots: The company has begun P-III (ECLIPSE) trial of ASP-1929 (photoimmunotherapy) + Keytruda for HNSCC, with first patient treated at a site across the US. Recruitment is underway in Japan, Taiwan & other regions This global study aims at assessing safety & efficacy of ASP-1929 + Keytruda vs Keytruda-based SoC as a 1L treatment…
January 24, 2025

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NEWS

Agenus Highlights Data from Five Studies of Botensilimab/Balstilimab (BOT/BAL) Regimen as Multiple lines of Therapy in Colorectal Cancer at ASCO GI 2025

Shots: P-II neoadj. studies were UNICORN (n=56) & NEST (n=24) in resectable CRC. UNICORN: 93% & 29% pCR with 100% & 36% pMR in dMMR/MSI-H & pMMR/MSS tumors, respectively; NEST: At 18 (NEST-1) & 9mos. (NEST-2) follow-up, all were ctDNA-ve w/o recurrences; pMR improved to 47% in MSS tumors in NEST-2 P-I/II study of BOT/BAL…
January 23, 2025

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Tris Pharma
NEWS

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots: The P-III (ALLEVIATE-1) study assessed analgesic efficacy of cebranopadol (400µg, QD) vs PBO for treating moderate-to-severe acute pain post abdominoplasty surgery Study depicted significantly reduced pain intensity as evaluated by Pain Numeric Rating Scale (NRS) AUC4-48 (1.34 mean hourly difference) and a well-tolerated safety with nausea being the common AE Tris will…
January 23, 2025

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NEWS

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025

Shots: The company will highlight data from P-I/II (CLINCH) trial of ATN-022 to treat advanced/metastatic gastric cancer in Australia & China at ASCO GI 2025 under the title, ‘Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)’ In the dose expansion phase (as of Nov 2024), 21 patients with CLDN18.2…
January 22, 2025

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Novo Nordisk
NEWS

Novo Nordisk Reports Headline Results from P-IIIb (STEP UP) Study of Semaglutide 7.2mg in Obese Adults without Diabetes

Shots: The P-IIIb (STEP UP) study assessed semaglutide (7.2mg) vs semaglutide (2.4mg) & PBO as an adjunct to lifestyle intervention in obese adults (n=1,407; BMI ≥30kg/m^2) without diabetes for 72wks. STEP program also includes STEP UP T2D study of semaglutide (7.2mg) in obese adults (n=512) with T2D for 72wks. Study met its 1EP, depicting…
January 20, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI Read More: Bayer Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine…
January 17, 2025

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