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Global Innovative Drug R&D newsletter: Eli Lilly, MSD,Tessa Therapeutics,Innate Pharma,GSK

Updated: Jul 11, 2023

1 First-Of-Its-Kind Head-to-Head Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention

Eli Lilly and Company announced results of the CHALLENGE-MIG clinical trial of Emgality® (galcanezumab-gnlm) and Nurtec® ODT (rimegepant orally disintegrating tablet), the first and only trial of its kind comparing two calcitonin gene-related peptide (CGRP) antagonist therapies. Emgality did not meet the study's primary endpoint, defined as statistical superiority to Nurtec ODT on the percentage of participants achieving a 50% or greater reduction in monthly migraine headache days. Response rates were similar.

2 KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Met Primary Endpoint of Progression-Free Survival as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

MSD announced that the Phase 3 KEYNOTE-811 trial investigating KEYTRUDA, in combination with trastuzumab and chemotherapy met one of its dual primary endpoints of PFS for the first-line treatment of HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA in combination with trastuzumab and chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with trastuzumab and chemotherapy in the ITT study population.

3 Tessa Therapeutics Announces Positive Results from CD30 CAR-T Combination Study with Nivolumab in 2nd line Hodgkin Lymphoma

Tessa Therapeutics presented encouraging safety and efficacy data from a combination study of its autologous CD30 CAR-T therapy with nivolumab. A total of 15 patients were enrolled of which 13 were treated with Nivolumab + CD30 CAR-T therapy. 10 patients reached End of Treatment (Post-Nivo Cycle 4) and were evaluable for response. Of the 10 patients 9 responded to the treatment with complete disappearance of tumor observed by PET/CT in 7 patients and partial reduction in tumor size observed in 2 patients. One patient had stable disease. Of note, no patients proceeded to receive ASCT as of the data cut off. All 10 patients reaching EOT (Post-Nivo Cycle 4) proceeded to additional Nivo cycles.

4 Innate Pharma Highlights Increased Lacutamab Clinical Activity From Interim Results of Phase 2 TELLOMAK Study With Updated Olsen Criteria

Innate Pharma announced that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody. Based on these criteria, results showed that lacutamab produced an increased global objective response rate (ORR) of 42.9% (95% confidence interval [CI], 24.5-63.5) in patients with KIR3DL2 ≥ 1% MF (cohort 2, n=21), including 2 complete responses and 7 partial responses. Clinical Benefit Rate remained unchanged at 85.7% [95% CI tbc]. In Cohort 3, comprising 18 patients with KIR3DL2 < 1% MF, findings remain unchanged.

5 GSK announces extension of FDA review period for momelotinib

GSK announced that the FDA has extended the review period of the NDA for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.



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