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NEWS

Cumberland Pharmaceuticals Reveals Topline Data from P-II (FIGHT DMD) Trial of Ifetroban for Duchenne Muscular Dystrophy Heart Disease

Shots: Cumberland reported topline data from P-II (FIGHT DMD) trial assessing ifetroban (150/300mg, QD) vs PBO in DMD pts (n=41) for 12mos.; funded via the US FDA orphan products grant Study showed that ifetroban (300mg) led to 3.3% overall LVEF improvement (1EP), with a 1.8% increase vs 1.5% decline; on comparison with matched natural…
February 5, 2025

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Pfizer New
NEWS

Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Shots: Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243) Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…
February 4, 2025

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NEWS

Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain

Shots: Algiax reported topline data from the P-IIa PoC trial assessing AP-325 (GABA-A modulator) vs PBO in 99 pts with peripheral post-surgical neuropathic pain in Germany, Spain, the Czech Republic, Belgium, & France Data showed rapid PI-NRS reduction in <2wks., sustained effects, plus significantly higher ≥50% & ≥70% responder rates with ~25% vs. 11% pts…
February 4, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Shots: Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…
January 31, 2025

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Roche
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Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer

Shots: The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…
January 30, 2025

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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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