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CHMP Recommends Serplulimab for First-Line ES-SCLC Treatment in Europe

  • The CHMP has issued a positive opinion for serplulimab as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
  • The recommendation is based on the phase 3 ASTRUM-005 trial, which demonstrated a statistically significant improvement in overall survival.
  • Patients treated with serplulimab plus chemotherapy showed a median OS of 15.8 months compared to 11.1 months with placebo plus chemotherapy.
  • Serplulimab has already been approved in China and Southeast Asia for ES-SCLC, offering a new treatment option worldwide.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

Cidara Therapeutics Doses First Subjects in Phase 2b Trial of CD388 for Influenza Prevention

  • Cidara Therapeutics has initiated the Phase 2b NAVIGATE trial to assess CD388 for pre-exposure prophylaxis against seasonal influenza.
  • The trial will enroll 5,000 healthy, unvaccinated adults across sites in the US and UK, evaluating different doses of CD388 versus placebo.
  • CD388, a drug-Fc conjugate, aims to provide universal protection against influenza A and B strains, regardless of immune status, with a single dose.
  • The primary endpoint is to compare rates of laboratory-confirmed influenza between CD388 and placebo groups during the influenza season.

BDTX-1535 Shows Promise in Relapsed/Refractory EGFR-Mutant NSCLC

  • BDTX-1535, a fourth-generation EGFR TKI, demonstrates encouraging clinical activity in relapsed/refractory EGFR-mutant non-small cell lung cancer (NSCLC).
  • A phase 2 trial showed a 42% objective response rate (ORR) in patients with osimertinib-resistant EGFR mutations, including C797S.
  • The 200 mg daily dose of BDTX-1535 was well-tolerated, with mostly mild to moderate adverse events and no new safety signals observed.
  • Black Diamond Therapeutics anticipates sharing initial results from the first-line cohort in Q1 2025 and discussing potential registration paths.

Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

NCT05256290RecruitingPhase 1
Black Diamond Therapeutics, Inc.
Posted 3/31/2022

A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions

NCT06072586RecruitingEarly Phase 1
St. Joseph's Hospital and Medical Center, Phoenix
Posted 10/18/2023

Reviva Pharmaceuticals' Brilaroxazine Shows Positive Phase 3 Results for Schizophrenia Treatment

  • Reviva Pharmaceuticals reported positive Phase 3 trial results for Brilaroxazine in schizophrenia, meeting the primary endpoint with a statistically significant reduction in PANSS total score.
  • Brilaroxazine, a serotonin-dopamine activity modulator (SDAM), demonstrated a 10.1-point reduction in PANSS score compared to placebo (p<0.001) at week four in the Phase 3 trial.
  • The company plans to file a New Drug Application (NDA) for Brilaroxazine in the first quarter of 2026, with potential applications beyond schizophrenia, including bipolar disorder and depression.
  • EF Hutton initiated coverage on Reviva Pharmaceuticals with a Buy rating and a price target of US$15.00, citing the positive Phase 3 data and potential market opportunities.

Pembrolizumab Plus Lenvatinib Shows Promise in Progressive Thyroid Cancer

  • A recent clinical trial evaluated the addition of pembrolizumab to lenvatinib for patients with progressive thyroid cancer resistant to radioactive iodine.
  • The combination therapy demonstrated an improved duration without relapse compared to the standard-of-care treatment with lenvatinib alone.
  • The study, published in Clinical Cancer Research, suggests a potential new treatment approach for this challenging patient population.
  • Led by Dr. Bryan Haugen, the multi-center trial offers hope for patients with limited options.

AstraZeneca's Durvalumab Receives Indian Approval for Expanded NSCLC Treatment

  • AstraZeneca Pharma India has received CDSCO approval to import and distribute durvalumab for an additional indication in India.
  • The approval covers the use of durvalumab with chemotherapy as neoadjuvant treatment, followed by durvalumab monotherapy after surgery.
  • This expands durvalumab's use to treat resectable non-small cell lung cancer (NSCLC) with tumors 4 cm or larger and/or node-positive cases.
  • Lung cancer is a significant cause of cancer-related mortality in India, with a notable portion having resectable NSCLC.

Zatolmilast Shows Promise in Treating Fragile X Syndrome

  • Zatolmilast, an experimental drug, has shown potential in improving cognitive and social functions in individuals with Fragile X syndrome.
  • A 2021 study indicated that zatolmilast improved memory and language skills in adult males with Fragile X over a 12-week period.
  • Two ongoing larger studies are evaluating zatolmilast's efficacy, potentially leading to the first FDA-approved treatment for Fragile X syndrome.
  • The drug targets an enzyme involved in memory and cognitive impairment, offering a new approach to managing Fragile X symptoms.

APE1's Role in DNA Repair Could Influence Cancer Clinical Trials

  • Researchers have elucidated the functional role of APE1, a protein crucial for initiating DNA damage repair, potentially impacting cancer survival rates.
  • The study reveals APE1's function as a 'molecular switch' that activates ATM signaling to repair single-strand breaks (SSBs), which can lead to more severe DNA damage.
  • A novel, highly purified plasmid DNA structure was developed, enabling the discovery of how APE1 directly activates ATM signaling for SSB repair.
  • These findings may enable scientists to test therapeutic targeting of overactive APE1 to improve cancer survival rates, influencing future clinical trials.

Advanced Practice Providers Enhance Myeloma Care Through Unique Patient-Centered Approach

  • Advanced Practice Providers (APPs) play a crucial role in managing multiple myeloma patients by coordinating care and managing treatment side effects.
  • APPs leverage their nursing experience and clinical training to offer a unique perspective, bridging the gap between bedside care and clinical decision-making.
  • APPs are increasingly involved in patient education, community outreach, and identifying candidates for clinical trials, expanding their role in myeloma care.
  • The integration of APPs enhances efficiency and streamlines patient care, particularly in academic medical centers offering advanced myeloma treatments.

Phase 3 Trials Target Advanced Prostate Cancer with Novel Therapies

  • A Phase 3 trial is underway to assess CAN-2409 immunotherapy combined with radiation for localized prostate cancer, aiming to improve disease-free survival.
  • Johnson & Johnson's Akeega, combining niraparib and abiraterone, is being evaluated in the AMPLITUDE study for metastatic castration-sensitive prostate cancer with HRR mutations.
  • Pfizer's mevrometostat, an EZH2 inhibitor, is under investigation in the MEVPRO-1 trial for metastatic castration-resistant prostate cancer after abiraterone treatment.

A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).

NCT06551324RecruitingPhase 3
Pfizer
Posted 10/21/2024

Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer

NCT01436968Active, Not RecruitingPhase 3
Candel Therapeutics, Inc.
Posted 9/1/2011

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

NCT04497844Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/23/2020

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