Melanoma Research Advances – 2019 in Review
During 2019, melanoma research continued its rapid pace of advancement, with FDA approval of a new adjuvant therapy treatment option, several first-in-human clinical trials, and significant progress towards earlier intervention. Researchers made remarkable progress in translational and basic research, focusing on expanding our understanding of treatment resistance, identifying new treatment targets, and improving melanoma detection and prevention.
New Adjuvant Therapy Treatment Option Approved by the FDA
Early in 2019, the US Food and Drug Administration (FDA) approved existing drug pembrolizumab (Keytruda®) for use in the adjuvant setting for patients with lymph node involvement following complete lymph node dissection. Adjuvant therapy, delivered after complete surgical removal of melanoma, is intended to reduce the risk of melanoma returning. In clinical studies, adjuvant therapy reduced melanoma recurrence by 15-20% compared to the standard of care (careful monitoring). Without adjuvant therapy, an estimated 60% of Stage III melanoma patients will relapse within three years of surgical resection.
This new indication expands the number of approved adjuvant therapies to include: interferon (Intron® and Sylatron®), ipilimumab(Yervoy®), nivolumab (Opdivo®), dabrafenib + trametinib (Tafinlar® + Mekinist®), and pembrolizumab (Keytruda®) – giving patients and doctors more options.
Clinical Trials Launched to Develop New Treatments
In 2019, dozens of new clinical trials were launched to test the safety, dosage and effectiveness of new and refined melanoma treatments. Just a few examples include:
- Vedanta Biosciences launched a first-in-human trial in patients with metastatic cancer, including melanoma patients, to test experimental therapy VE800 in combination with the PD1 immune-checkpoint inhibitor nivolumab. VE800 is believed to modulate the microbiome to increase the immune systems’ attack on tumors (NCT04208958).
- Evelo Biosciences launched a clinical trial to test its microbiome modulator EDP1503, in combination with the PD1 immune-checkpoint inhibitor pembrolizumab, among patients with advanced melanoma who did not respond to PD1 monotherapy. (NCT03595683)
In total, more than 500 melanoma-focused clinical trials are active in the United States, including over 300 that are actively recruiting patients. Learn more about clinical trials and how they may be right for you.
Testing Treatments Before Surgery – In the “Neoadjuvant” Setting
Over the last decade, significant progress has been made in better treating metastatic, Stage 4 melanoma. We’ve also seen many of the same drugs approved for stage 4 patients go on to earn approval in the adjuvant – or post-surgical – setting for patients with Stage 3 melanoma. Building on these successes, researchers have also wondered if giving the drugs before (rather than after) surgery – in the so-called neoadjuvant” setting – might be even more effective. There has been an explosion of clinical trials testing drugs and other treatments, including intralesional therapies, before surgery.
Neoadjuvant therapy for melanoma is not yet FDA approved and remains an area for research and clinical investigation. With the growing interest in the neoadjuvant field, the FDA to convene a public workshop entitled Approaches to Neoadjuvant Treatment for Melanoma. The goals of the workshop were to help define which patients should be included in neoadjuvant clinical trials, how these trials are best designed, how to minimize the risk of adverse events for patients, and how to select the optimal clinical trial endpoints. Videos, and archived presentations, from the workshop are freely available here.
Looking Ahead in 2020 – ‘Triplets Therapies’
Several ongoing clinical trials are expected to report results in 2020. Melanoma researchers got an early highlight of some of these promising results in December, with the announcement from Genentech, a member of the Roche Group, of positive results in its Phase 3 trial testing “triplet therapy” in advanced melanoma. Genentech’s triplet therapy combines the PD-L1 inhibitor atezolizumab (Tecentriq®) to the combined BRAF/MEK targeted therapies cobimetinib (Cotellic®) and vemurafenib (Zelboraf®). We eagerly await the publication of the specific data result early this year. A similar ongoing triple-therapy Phase 3 trial from Novartis, combining the PD1 inhibitor spartalizumab to dabrafenib and trametinib, is also expected to report results this year, after publishing promising Phase 1 results in 2019.
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