NovoCure Positions Itself for Nearing Clinical Readouts

Bill Doyle, executive chairman of the board of directors for NovoCure, said 2019, which included the U.S. approval of the first treatment for mesothelioma in 15 years, was an incredible year “on all fronts” for the company.

Bill Doyle, executive chairman of the board of directors for NovoCure, said 2019, which included the U.S. approval of the first treatment for mesothelioma in 15 years, was an incredible year “on all fronts” for the company.

That was the message Doyle and other NovoCure executives delivered in San Francisco at the annual J.P. Morgan Healthcare Conference. Doyle spoke to BioSpace following the conclusion of the conference where he touted the achievements the company has made with its Tumor Treating Fields platform in solid tumors. That success has so far led to two approvals from the U.S. Food and Drug Administration and a strong clinical pipeline. Also, Doyle said this past year the company received Medicare reimbursement approval, which is a significant accomplishment. That string of achievements, he said, has led to the company being on a solid financial footing that will allow it to invest in a much broader clinical program to improve the validity of their therapy platform in other cancers.

NovoCure’s TTF platform uses the natural electrical properties of cells and seeks to prohibit the growth of cancer cells by disrupting their capabilities of rapid division. By inhibiting the growth, the cancer cells die. Doyle said the TTF platform is compatible with other types of therapy, including radiation treatment, chemotherapy and immunotherapy. He noted that NovoCure’s platform does not compete with other therapies on the market, but works hand-in-hand with them to halt the spread of cancer.

“We don’t add to the toxicity, just to the efficacy,” Doyle said of the TTF platform.

In addition to the mesothelioma treatment, in 2016 NovoCure also won approval from the U.S. Food and Drug Administration approved its TTF delivery system for glioblastoma patients. The delivery system, called Optune, was approved in combination with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.

As the new year unfolds, Doyle said the company is using its firm financial footing to improve its TTF platform, even as it pushes ahead with its clinical trial programs. NovoCure currently has four Phase IIIs in cancer trials, all of which are larger than the mesothelioma indication, he said. In March, the company launched a Phase III trial testing the efficacy of its Tumor Treating Fields platform combined with paclitaxel in patients with recurrent, platinum-resistant ovarian cancer. Data from that trial isn’t expected for several years though, until 2024.

But, other Phase III trials will read out much sooner. Data from the company’s Phase III METIS trial in brain metastases from non-small cell lung cancer is expected next year. The primary endpoint of the trial is time to first cerebral progression, with secondary endpoints including time to neurocognitive failure, overall survival and radiological response rate following study treatments. Final data from its pivotal Phase III LUNAR trial in non-small cell lung cancer is expected in 2022, as is final data from the Phase III PANOVA-3 trial in locally advanced pancreatic cancer.

NovoCure is also anticipating interim data from some Phase III trials. The company expects an interim analysis of pivotal Phase III LUNAR trial in non-small cell lung cancer in the second half of this year; interim results of the PANOVA-3 trial will be revealed in 2021; and an interim analysis of the late-stage ovarian cancer trial started last year is expected in 2022.

“We have a big and robust clinical program. These dates will be here before you know it and, if we’re not prepared, we won’t be ready to handle things,” Doyle said.

Preparation means, in part, continued growth. Not only is the company investing in advancement of its own platform, Doyle said NovoCure is focused on building a global infrastructure. The company is active in most major markets in Europe and Asia. Doyle believes the company is close to cracking the final major market, China. Doyle said NovoCure “laid the groundwork” for approval in China last year and once that approval is given, the company wants to be able to immediately launch in that market.

Looking at the successes from the past year, Doyle reiterated they were crucial triumphs that have set the company on the path to a bright future of becoming an innovative leader in taking on some of the most aggressive cancers.

For more information on mesothelioma treatments, please visit Mesothelioma.com

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