On April 27, 2020 Novocure (NASDAQ: NVCR) reported that an abstract highlighting results from the EF-19 post-approval registry trial studying Optune for the treatment of recurrent GBM will be presented as a virtual poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting I, taking place April 27-28, 2020 (Press release, NovoCure, APR 27, 2020, View Source [SID1234556647]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The FDA-mandated EF-19 post-approval registry trial studied Optune as a monotherapy for the treatment of recurrent GBM in 192 patients compared to the 117 recurrent GBM patients who received best standard of care chemotherapy in Novocure’s EF-11 registration trial. Optune as monotherapy reduced the risk of death with fewer adverse events compared to best standard of care chemotherapy. For patients who received at least one course of therapy, Optune prolonged survival by a median 1.7 months. No new safety signals were noted. The EF-19 data confirm the effectiveness and safety of Optune as monotherapy and further strengthen Optune’s clinical profile in recurrent GBM.
The AACR (Free AACR Whitepaper) Virtual Annual Meeting I will feature a selection of high-impact proffered paper presentations in several clinical trial plenary sessions and clinical trial poster sessions, along with minisymposia featuring basic and translational science. The virtual meeting will be available free to everyone, although attendees will be asked to register to participate.
Details for the AACR (Free AACR Whitepaper) 2020 Virtual Meeting I presentations are as follows:
Title: EF-19 – A post-approval registry study of TTFields for the treatment of recurrent glioblastoma (GBM)
Lead author: Jay-Jiguang Zhu, University of Texas Health Science Center, Houston, TX
Poster #: CT211
Session: VPO.CT03. Phase III Clinical Trials
Date and Time: April 27, 2020 9:00 AM – 6:00 PM
URL: View Source!/9045/presentation/10714
Title: HEPANOVA: Interim safety analysis from a phase 2 study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with sorafenib in advanced hepatocellular carcinoma (HCC)
Lead author: Eleni Gkika, University of Freiburg, Freiburg, Germany
Poster #: CT186
Session: VPO.CT02. Phase II Clinical Trials
Date and Time: April 27, 2020 9:00 AM – 6:00 PM
URL: View Source!/9045/presentation/10686
Title: Optimizing Tumor Treating Fields therapy for recurrent glioblastoma with targeted and individualized skull remodeling surgery. A multi-center randomized phase 2 trial
Lead author: Nikola Mikic, Aarhus University Hospital, Aarhus, Denmark
Poster #: CT184
Session: VPO.CT02. Phase II Clinical Trials
Date and Time: April 27, 2020 9:00 AM – 6:00 PM
URL: View Source!/9045/presentation/10684
Title: PriCoTTF trial: A phase I/II trial of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma
Lead author: Sied Kebir, University Hospital Essen, Essen, Germany
Poster #: CT106
Session: VPO.CT01. Phase I Clinical Trials
Date and Time: April 27, 2020 9:00 AM – 6:00 PM
URL: View Source!/9045/presentation/10605
Title: Final results for OptimalTTF-1: Optimizing Tumor Treating Fields with targeted skull remodeling surgery for first recurrence glioblastoma: Phase 1 trial
Lead author: Nikola Mikic, Aarhus University Hospital, Aarhus, Denmark
Poster #: CR103
Session: VPO.CT01. Phase I Clinical Trials
Date and Time: April 27, 2020 9:00 AM – 6:00 PM
URL: View Source!/9045/presentation/10602
About Optune
Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.
Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.
Approved Indications
Optune is intended as a treatment for adult patients with histologically-confirmed GBM.
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial GBM following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
Important Safety Information
Contraindications
Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.
Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions
Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.
The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.
The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.
If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.
Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.