Regeneron Halts Garetosmab Trial Amid Patient Deaths; Roche’s Tecentriq-Avastin Combo Approved in EU for Unresectable HCC
Sanofi
Pharmaceutical R&D Developer
AstraZeneca
Biopharmaceutical Manufacturer
[2020.11.03 R&D NEWS]Karyopharm’s XPO1 inhibitor achieves positive top-line results in Phase 3 trial; CureVac’s COVID-19 vaccine shows positive Phase 1 clinical trial results, paving the way for initiation of Phase 2b/3 trials; Sanofi/AstraZeneca’s jointly developed first-in-class monoclonal antibody receives clinical trial approval in China; Novartis and Poseida Therapeutics’ autologous CAR-T therapy for solid tumors sees clinical hold lifted for prostate cancer indication...
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[Drug Development]
Regeneron Urgently Halts Garetosmab Clinical Trial Due to Multiple Patient Deaths
Recently, after multiple patient deaths, Regeneron announced the suspension of the LUMINA-1 trial for its rare bone disease drug Garetosmab (REGN2477). The company stated that it is currently reviewing relevant trial data to better understand the drug’s risk/benefit profile.
Today, Karyopharm announced that its innovative selective inhibitor of nuclear export (SINE), Xpovio (selinexor), met the primary endpoint of significantly prolonging progression-free survival in patients with advanced unresectable dedifferentiated liposarcoma, reducing the risk of disease progression or death by approximately 30% compared with placebo.
On the 29th, Abbisko Therapeutics announced that a pooled analysis of results from two Phase 1 clinical trials of its investigational dual ROS1/NTRK inhibitor, taletrectinib, was published in JTO Clinical and Research Reports. The drug demonstrated meaningful clinical activity and a favorable safety profile, showing significant potential to become a best-in-class ROS1/NTRK inhibitor.
Today, CureVac announced that its mRNA-based COVID-19 vaccine candidate, CVnCoV, demonstrated favorable safety and immunogenicity in Phase 1 clinical trials. The candidate vaccine was well tolerated across all tested doses (2–12 µg). In addition to demonstrating T-cell activation, it also induced a robust neutralizing antibody immune response.
[Drug Approval]
On the 2nd, Roche announced that the European Commission had approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Latest CDE Public Notice: Roche’s Marketing Application for the Innovative Influenza Drug Baloxavir Marboxil Tablets (English Brand Name: Xofluza) Submitted in China Proposed for Priority Review; Proposed Indication: For the Treatment of Influenza in Patients Aged 12 Years and Older, Including Those at High Risk for Influenza-Related Complications
New Immunotherapy Drug Libtayo for Advanced Lung Cancer Reduces Mortality by 43% in Clinical Trials
Recently, the U.S. FDA accepted the supplemental Biologics License Application (sBLA) for the PD-1 inhibitor Libtayo and granted it Priority Review designation for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 ≥50%. A regulatory decision is expected by the end of February next year.
Recently, Poseida announced that the U.S. FDA has lifted the clinical hold on the Phase I trial of P-PSMA-101 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and the company plans to resume the trial immediately.
The latest public announcement on the CDE website indicates that AstraZeneca’s Class 1 new drug, nirsevimab injection, has received an implicit approval for clinical trials. The proposed indication is for the prevention of lower respiratory tract diseases caused by respiratory syncytial virus (RSV). This drug is a monoclonal antibody targeting RSV, jointly developed by Sanofi and AstraZeneca, featuring an extended half-life and intended for the prevention of RSV infection.
Recently, Luoxin Pharmaceutical submitted a Class 4 generic marketing application for Urapidil Hydrochloride Injection. Data from Menet shows that urapidil is the top-selling antihypertensive drug, with sales exceeding RMB 1 billion for the first time in 2019. Its growth rate has exceeded 10% in each of the past two years, and even during the first half of 2020, when hospital sales were impacted by the pandemic, it still achieved a growth rate of approximately 8%, demonstrating significant market potential.
[Latest Research]
LncRNA CASC9: A Driver of Gefitinib Resistance in Non-Small Cell Lung Cancer
CASC9 can recruit the histone methyltransferase EZH2 to inhibit the tumor suppressor DUSP1, ultimately enhancing resistance to gefitinib. Furthermore, ectopic expression of DUSP1 can increase sensitivity to gefitinib by inactivating the ERK signaling pathway.
The research team believes that for patients undergoing breast-conserving surgery, with tumor bed boost, hypofractionated whole-breast radiotherapy and conventional whole-breast radiotherapy have similar effects on controlling 5-year local recurrence and toxicity. This provides more supporting evidence for Chinese early-stage breast cancer patients to receive hypofractionated treatment.
Recently, two studies published simultaneously in the top academic journal Cell have groundbreakingly demonstrated another anti-cancer force within the immune system. This force originates from the innate immune system.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.