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Trial Shows Immunotherapies Extend Life with Melanoma

T-cell lymphocyte

Colorized scanning electron micrograph of a T lymphocyte (NIAID)

15 July 2019. First results from a clinical trial show a combination of immunotherapies extends survival among patients with melanoma, but shorter periods for other solid-tumor cancers. Top-line findings from the trial were released today by cancer biotechnology company Neon Therapeutics Inc. in Cambridge, Massachusetts.

In the trial, Neon Therapeutics is testing a personal vaccine for cancer, code-named NEO-PV-01 with the immune checkpoint inhibitor therapy nivolumab, marketed as Opdivo by drug maker Bristol Myers Squibb. Neon Therapeutics develops cancer treatments using neoantigens, peptides — short protein chains — expressed by specific genetic alterations and found on the surface of tumor cells, which can be unique to an individual.

Neon’s platform takes blood samples from a patient’s tumor and genomically sequences the tumor’s DNA and RNA to find mutations producing the cancer-causing proteins, including neoantigens. The technology uses machine-learning algorithms to predict which neoantigens are most likely to generate strong immune responses, which form the basis of a vaccine personalized for the patient. Neoantigens targeted by the vaccine then bind to immune system cells that generate T-cells for attacking and destroying the tumor.

Nivolumab is an immune checkpoint inhibitor that treats cancer by blocking proteins keeping the immune system from responding to cancer cells, and allowing tumors to grow unchecked. Synthetic antibodies in nivolumab open the checkpoints stopping T-cells in the immune system, allowing immune responses to attack tumor cells.

The early-stage clinical trial recruited 82 patients from 9 cancer centers in the U.S. with 3 types of solid-tumor cancer: metastatic or advanced melanoma, non-small cell lung cancer, and bladder cancer. Melanoma is an aggressive form of skin cancer, while non-small cell lung cancer is the most common form of the disease, covering 85 percent of cases. The study team looked primarily for adverse effects from the treatments, but also tracked participants for up to 2 years, measuring the time patients survived after treatment, both overall and without the cancer progressing (getting worse), as well as responses of their tumors to the treatments.

Initial results from the trial show patients with melanoma appear to benefit the most from the combination of neoantigens and nivolumab. Among the 34 melanoma patients tracked for a median of more than 13 months, nearly half (47%) report a full or partial response to the treatments. In that period, survival time of melanoma patients without the cancer progressing did not reach a median, which means fewer than half of the patients reported their cancers growing or spreading.

Patients with non-small cell lung or bladder cancer do not fare quite as well. Of the 27 lung cancer and 21 bladder cancer patients, 22 and 24 percent respectively report full or partial responses to the combination of neoantigens and nivolumab. The lung cancer patients were tracked for a median of 12 months and bladder cancer patients were followed for nearly 15 months. During those periods, each group experienced a median survival time of 5.6 months without their cancers progressing.

The clinical trial does not have a control or comparison group, but compares progression-free survival times to historical averages for individuals receiving nivolumab alone: 3 to 7 months for melanoma, 2 to 4 months for non-small cell lung cancer, and 2 to 3 months for bladder cancer. No serious adverse effects were reported by patients receiving the combination therapy, with low-grade injection-site reactions, fatigue, and flu-like symptoms as the most common complaints.

Neon Therapeutics plans mid-stage trials of its neoantigens and checkpoint inhibitors. The company was founded in 2015 by researchers from Dana-Farber Cancer Center in Boston, MD Anderson Cancer Center in Houston, Washington University in St . Louis, Netherlands Cancer Center, and the Broad Institute affiliated with Harvard and MIT. Science & Enterprise reported on a pilot test of its neoantigen treatments in July 2017.

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