Articles Posted in Mesothelioma Treatment

The Food and Drug Administration (FDA) recently gave approval to the first new mesothelioma drug treatment combination for patients in the last 16 years. The drug combination, Opdivo (nivolumab) in combination with Yervoy (ipilimumab) are a first-line treatment for adults with malignant pleural mesothelioma that cannot be removed by surgery.

“Today’s approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”

Malignant pleural mesothelioma is a serious form of cancer that affects the lining of the lungs, and is caused by exposure to carcinogenic asbestos fibers. According to the FDA, about 20,000 Americans develop malignant pleural mesothelioma each year and accounts for most of the mesothelioma cases recorded. Furthermore, most of the patients diagnosed with malignant pleural mesothelioma are not able to have their tumors operated on and this prognosis creates a generally poor survival rate.

A Sweedish pharmaceutical company recently announced it has seen positive results with a therapeutic cancer vaccine that could potentially be used in combination with other immuno-oncology drugs to treat metastatic malignant mesothelioma. The results of the clinical trials showed that more than half of the participants did not demonstrate disease progression, and none of the patients experienced unexpected safety issues which showed that the drug combinations were well-tolerated.

Drugmaker Ultimovacs ASA conducted the study on a group of 20 mesothelioma cancer patients who received a combination of the company’s UV1 cancer vaccine and pembrolizumab, PD-1 checkpoint inhibitor. This group of patients participated in the company’s Phase I study for the drug combination, which is designed to test the safety, tolerability, and initial signs of clinical response in patients treated with UV1 in combination with pembrolizumab.

Commenting on the study, Ultimovacs Chief Medical Officer released a statement saying, “The safety profile observed to date in this first cohort of the PD-L1 combination study is consistent with the promising safety profiles seen in our earlier Phase I trials. For the further development of our vaccine, it is important to demonstrate that UV1 can be combined with different classes of immunotherapies without compromising on safety.”

A recently published Japanese study conducted by university oncologists shows improved outcomes for certain mesothelioma patients who undergo near-infrared irradiation treatment used in combination with a cancer-targeting compound. The experiment, which was conducted on laboratory mice, as well as human cells with malignant mesothelioma found that near-infrared photoimmunotherapy was an effective and low-risk method for killing cancer cells without harming the surrounding tissues.

Conducted by Nagoya University, the treatment on the subjects utilized a cancer-targeting antibody compound, designed to a specific structure on the cancer cells, and a photo-absorber called IR700. When the near-infrared light is shone on the cancer-infected part of the body, the antibody compound aggregates on the membranes of the tumor cells, which ruptures the cells and kills the tumor.

“The lungs and chest cavity contain a large amount of air and are thus very good at effectively transmitting near-infrared light,” says Kazuhide Sato of Nagoya University. “NIR-PIT is a safe phototherapy option that can target a region of interest. The antibody-IR700 conjugate is also non-toxic to the body in the absence of near-infrared light irradiation. We thus thought that NIR-PIT could be an effective strategy for controlling localized MPM.”

A recent study examining a new therapy in an emerging cancer treatment known as T-cell therapy has shown positive results, according to an executive with the clinical-stage immunotherapy company that developed the treatment. Developed by TCR² Therapeutics Inc., TC-210 TRuC-T cell products were given to five mesothelioma cancer patients who took part in the study. The results showed a median reduction range from the sum of the diameters of the tumors of 42%.

“We are delighted that our very first dose of TC-210 induced consistent tumor regression and clinical benefit in heavily pre-treated cancer patients,” said Garry Menzel, Ph.D., of TCR² Therapeutics. “There are very few options for patients with solid tumors and those expressing mesothelin represent a significant frontier of unmet medical need. While these are early data requiring further study, we are encouraged by the potential of our TRuC-T cells as we continue to enroll and treat patients with the goal of quickly finding a recommended Phase 2 dose for TC-210.”

According to the research company, the primary focus of the Phase 1 portion of the study on TC-210 was to “define the safety profile of TC-210 in patients whose tumors overexpress mesothelin and to determine the recommended Phase 2 dose (RP2D).” One of the key clinical findings from the study on the five patients found that TC-210 was generally well tolerated by the group.

A recent analysis published in the Annals of Surgical Oncology determined that peritoneal mesothelioma patients who underwent surgery had a far better survival rate compared to those who did not have surgical intervention to treat their cancer. The study analyzed the survival rates of over 2,000 patients diagnosed with peritoneal mesothelioma between 2003 and 2014 and found that for those who underwent “radical” surgery, the survival period was up to five times longer than those who did not.

Examining the data, the study found that about half of the patients did not undergo any kind of surgery to treat their peritoneal mesothelioma cancer, and had an average survival rate of about seven months after diagnosis. On the other hand, those who underwent radical surgery, about 34% of those looked at, had an average survival rate of just over three years. Another group, which underwent a combination of surgery and chemotherapy, had an average survival rate of just under three and a half years.

According to the study, prior to the turn of the century, the average life expectancy of a patient diagnosed with peritoneal mesothelioma was less than a year. The study recommends that doctors suggest surgery to their newly diagnosed patients who are able to undergo such procedures, in order to extend their lives.

A recently published study from the Netherlands appears to indicate that a combination of a pair of immunotherapy drugs can help improve the prognosis of mesothelioma patients with tumors that are not able to be removed through surgery. The experiment, named checkmate 743, compared the use of first-line nivolumab and ipilimumab versus platinum-based chemotherapy in a group of over 600 mesothelioma cancer patients, and showed significant tumor shrinkage for a large portion of the participants who were given the two-drug combination.

Conducted by The Netherlands Cancer Institute and The University of Leiden, in Amsterdam, the study showed a two year survival rate in 41% of the 303 participants given the combination of nivolumab and ipilimumab, contrasted with a 27% survival rate of the 302 patients  undergoing platinum-based chemotherapy. For many decades, chemotherapy has been the standard of care for mesothelioma patients diagnosed with tumors that cannot be operated on or otherwise surgically removed.

“CheckMate 743 met its primary endpoint of statistically improved OS with nivolumab + ipilimumab vs standard of care chemotherapy in first-line treatment of patients with mesothelioma,” said Paul Baas, M.D., who presented the study’s findings at The International Association for the Study of Lung Cancer conference. “These clinically meaningful data represent the first positive phase 3 trial of immunotherapy in first-line MPM and should be considered as a new standard of care.”