pemlimogene merolisbac (JNJ-64041757) / Novartis - LARVOL DELTA

An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung (clinicaltrials.gov) - P1/2 | N=12 | Terminated | Sponsor: Janssen Research & Development, LLC | Phase classification: P1b/2 ➔ P1/2

Monotherapy • Phase classification • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MSLN • PD-L1

First-In-Human Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, for Non-Small Cell Lung Cancer (WCLC 2017) - P1; "The RP2D of JNJ-757 is 10[9] CFU, with a safety profile consistent with other LADD Lm-based agents such as CRS-207. Both innate and mesothelin-specific adaptive immune responses were demonstrated in multiple patients. Recruitment in the trial continues to further characterize the safety profile and immune response, and a phase 1b/2 trial with JNJ-757 and nivolumab is planned."

Non Small Cell Lung Cancer

JNJ-64041757 (JNJ-757), a Live, Attenuated, Double-Deleted Listeria monocytogenes-Based Immunotherapy in Patients With NSCLC: Results From Two Phase 1 Studies. (PubMed, JTO Clin Res Rep) - P1, P1b/2 | "As monotherapy, JNJ-757 was immunogenic and tolerable, with mild infusion-related fever and chills. The limited efficacy of JNJ-757, alone or with nivolumab, did not warrant further investigation of the combination."

Clinical • IO biomarker • Journal • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor • MSLN

Preliminary immunogenicity, safety, and efficacy of JNJ-64041757 (JNJ-757) in non-small cell lung cancer (NSCLC): Results fromtwo phase 1 studies. (ASCO 2019) - P1, P1b/2; "Background: The immunogenicity, safety, and efficacy of JNJ-757, a live attenuated, double-deleted Listeria monocytogenes-based immunotherapy expressing human mesothelin (MSLN), were evaluated in patients (pts) with advanced NSCLC (adenocarcinoma) as monotherapy (phase 1) and in combination with nivolumab (phase 1b/2). As monotherapy, JNJ-757 was tolerable with mild infusion-related fever and chills supporting the initiation of the combination therapy study. However, the risk-benefit profile of JNJ-757+nivolumab, did not support proceeding to phase 2. Clinical trial information: NCT02592967, NCT03371381"

Clinical • P1 data

Aduro BioTech CEO sells $688,500.00 in stock (ADRO) (Dakota Financial News) - "Aduro BioTech...CEO Stephen T. Isaacs sold 25,000 shares of the stock in a transaction that occurred on Monday, November 16th. The shares were sold at an average price of $27.54, for a total transaction of $688,500.00."

Stock price • Oncology

Safety & Immunogenicity of JNJ-64041757, Live-attenuated Double-deleted Listeria Immunotherapy, in Subjects With Non Small Cell Lung Cancer (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Janssen Research & Development, LLC; Trial primary completion date: Apr 2017 ➔ Mar 2020

Trial primary completion date • Biosimilar • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bristol-Myers Squibb to present new data on 20 types of cancer from across its oncology portfolio at ASCO and EHA 2019 (Businesswire) - "Bristol-Myers Squibb Company...announced the presentation of data from across the company’s oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2019 in Chicago, May 31-June 4, and the 24th Annual Congress of the European Hematology Association (EHA) in Amsterdam, June 13-16. Data from over 90 Company-sponsored studies, investigator-sponsored studies and collaborations evaluating oncology compounds and early translational medicine across 20 types of cancer will be featured at the two meetings."

Clinical data