What’s New in Clinical Research This Week?
Here’s a round-up of some of the top news in clinical research this week!
Roche Announces the FDA Approval of OCREVUS ZUNOVO™ for the Treatment of Relapsing and Progressive Multiple Sclerosis
Roche announced that OCREVUS ZUNOVO™ had been approved as the first and only twice-a-year, healthcare professional-administered approximately 10-minute subcutaneous injection approved for both these forms of multiple sclerosis. The treatment gives people living with MS – which affects more than 2.9 million people worldwide – more treatment options.
Bristol Myers Squibb Presents Landmark 10-Year Follow-Up Data from CheckMate -067 Which Showed Continued Durable Long-Term Survival Benefit with Opdivo® plus Yervoy® in Advanced Melanoma
Bristol Myers Squibb announced 10-year follow-up data from CheckMate -067, a randomized, double-blind, Phase 3 clinical trial, which showed continued durable improvement in survival with first-line Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab) therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma.
AstraZeneca’s Imfinzi Plus Imjudo Demonstrated Unprecedented Overall Survival in Advanced Liver Cancer with One in Five Patients Surviving Five Years in HIMALAYA Phase III Trial
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment.
Boehringer’s Nerandomilast Meets Primary Endpoint in Pivotal Phase-III FIBRONEER™-IPF Study
On Tuesday, Boehringer Ingelheim announced that the FIBRONEER™-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo.
Relief Therapeutics Completes Clinical Phase in RLF-OD032 Proof-of-Concept Study; Topline Results Expected in October 2024
Relief Therapeutics announced that it has completed dosing in its proof-of-concept clinical study of RLF-OD032 for the treatment of phenylketonuria (PKU), a rare inherited disorder affecting phenylalanine metabolism.
MIRA Pharmaceuticals Advances Ketamir-2 Development Following Phase 1 Design Completion, Focusing on Early Clinical Efficacy Demonstration for Neuropathic Pain in 2025
MIRA Pharmaceuticals, Inc. announced significant progress in the clinical development planning for its novel oral ketamine analog. As part of its strategic development plan, MIRA is prioritizing the early demonstration of clinical efficacy, potentially as early as 2025, through innovative Phase I/II study designs.
AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease
AC Immune SA announced that it will receive the second ReTain-related milestone payment (CHF 24.6 million) under its agreement with Janssen Pharmaceuticals, Inc. (Janssen), a Johnson & Johnson company.
Johnson & Johnson’s RYBREVANT®▼ (amivantamab) Plus Chemotherapy Shows Positive Overall Survival Trend Versus Chemotherapy in Patients with Previously Treated EGFR-mutated Lung Cancer
Johnson & Johnson today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT®▼ (amivantamab) combined with chemotherapy led to a favourable trend toward improved overall survival (OS) compared to chemotherapy alone.
Transgene and BioInvent’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase I/IIa Trial in Solid Tumors that Failed Previous Treatments
Transgene and BioInvent International announced new initial data from their ongoing Phase I/IIa study on the multifunctional oncolytic virus BT-001, demonstrating antitumor activity in patients who failed previous treatments.
AAVantgarde announces first patient dosed in First-In-Human Phase 1/2 LUCE-1 study, evaluating AAVB-081 (Dual-AAV) in retinitis pigmentosa related to Usher Syndrome type 1B
AAVantgarde announced that the first subject has been dosed in the LUCE-1 trial, a Phase 1/2 open label clinical trial to assess safety and tolerability of AAVB-081, using the company’s proprietary dual hybrid gene therapy platform to deliver MYO7A protein in subjects with retinitis pigmentosa related to Usher Syndrome Type 1B (USH1B).
Aptevo Therapeutics and Alligator Bioscience Announce Data from Phase 1 ALG.APV-527 Monotherapy Trial Showing 60% of Evaluable Patients Achieved Stable Disease in Solid Tumor Study
Aptevo Therapeutics and Alligator Bioscience AB announced positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors likely to express the tumor antigen 5T4. The results, which include clinical activity, safety, tolerability outcomes, pharmacokinetics and pharmacodynamics were presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain.
Jazz Pharmaceuticals Presents Updated Phase 2 Data for Zanidatamab Demonstrating Increased mPFS in HER2-Positive Metastatic Gastroesophageal Adenocarcinoma at ESMO 2024
Jazz Pharmaceuticals plc announced updated data, including median progression-free survival (mPFS) and overall survival (OS) findings, from the Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy as first-line treatment for patients with HER2-expressing advanced or metastatic gastroesophageal adenocarcinoma (mGEA).
Positive Phase III Results Show Roche’s Xofluza Significantly Reduces the Transmission of Influenza Viruses
Roche announced positive topline results of the phase III CENTERSTONE study of Xofluza® (baloxavir marboxil), an antiviral, showing a reduction in the transmission of influenza viruses. The study met its primary endpoint, demonstrating that a single, oral dose of Xofluza taken by people infected with influenza significantly reduced the likelihood of others in their household contracting the virus.
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