NovoCure Limited (NASDAQ:NVCR) Q2 2020 Earnings Conference Call - Final Transcript
Jul 30, 2020 • 08:00 am ET
William F. Doyle
to further unlock the potential of the Tumor Treating Fields platform. We believe the Tumor Treating Fields's mechanism of action is broadly applicable to solid tumor cancers.
Our fundamental scientific research spends two decades and then all of our pre-clinical research to-date Tumor Treating Fields has demonstrated a consistent anti mitotic product effect. Building upon the solid foundation of compelling pre-clinical evidence, we are executing a strategy to advanced Tumor Treating Fields therapy through Phase 2 pilot trials, Phase 3 pivotal trials and Phase 4 post-marketing studies, across multiple solid tumor cancer indications. Investments supporting the advancement of both our science and technology remain core to our long-term value creation strategy, and there have been several recent notable developments that I would like to highlight today.
In July, we enrolled the last patient in the HEPANOVA trial, a Phase 2 pilot trial, studying Tumor Treating Fields in combination with sorafenib in patients with advanced liver cancer. Tumor Treating Fields have demonstrated efficacy in vitro and in vivo models of a hepatocellular carcinoma and can be delivered to the abdominal region. In pre-clinical studies Tumor Treating Fields plus sorafenib led to reduced viability and clonogenicity of hepatocellular carcinoma cells as well as increased apoptosis and autophagy in vitro and to a significant reduction in tumor volumes in vivo.
Our preclinical data informed the design of the Phase 2 HEPANOVA trial. HEPANOVA was designed to detect an overall response rate by 20% in 25 patients treated with Tumor Treating Fields, compared to a 4.5% overall response rate calculated from historical controls. We expect final data collection six months from the last patient enrollment and look forward to seeing the results in early 2021. Beyond our internal development efforts, Tumor Treating Fields therapy is of increasing interest to the broader scientific and clinical research communities.
In July, we announced a clinical trial collaboration agreement with MSD, a trade name of Merck, to develop Tumor Treating Fields together with the anti-PD-1 therapy KEYTRUDA for the treatment of first line non-small cell lung cancer. Preclinical studies suggest the use of Tumor Treating Fields together with anti PD-1 therapy can augment the immune response resulting in improved tumor control, and we are currently studying the combination of Tumor Treating Fields and anti PD-1 therapies as a second line treatment for Stage 4 non-small cell lung cancer in our LUNAR trial.
In collaboration with Mark, we will expand our research in lung cancer to study the combination of Tumor Treating Fields concomitant KEYTRUDA for first line treatment of Stage 3, non-small cell lung cancer in a Phase 2 pilot study designed to approve approximately 66 patients in the United States. Objective response rate is the primary endpoint of the study and secondary end points include overall and progression-free survival. Keynote 36 is expected to begin in the second half of 2020.
We look forward to generating clinical data from this important combination study in first line non-small cell lung cancer with a global leader in oncology. These