On Tuesday, April 19 Dr. Maura Gillson, the Principal Investigator, presented a study in a meeting of Cancer Research Association of America (AACR) held at New Orleans. These results showed that Opdivo produced by Bristol Myers Squibbs (BMS) increases the rate of survival among the patients who are suffering from the head and neck carcinoma.
The overall increase in survival rate was especially observed in those patients who were suffering from either metastasis or recurrence of head and neck cancer in comparison with the other standard chemotherapeutic drugs after receiving a platinum therapy.
The study was conducted by comparing the use of Opdivo with three other standard treatment strategies for cancer of head and neck. The choice of these standard treatment plans was left entirely on Investigators discretion. On January 28, BMS had to cease the clinical trials of Opdivo before time, because of the conclusion drawn by an independent Data Monitoring Committee (DMC). This committee concluded that the phase 3 clinical trials of Opdivo has achieved its primary end point goals and demonstrated the superiority over its comparative control options. This can now be used as a preferred option in the patients suffering from the metastatic and recurrent platinum refractory head and neck carcinoma.
“With the results of CheckMate 141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options,” said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. “They named these clinical trials as Checkmate-141 and were looking ahead in continuing the advanced clinical developmental program of Opdivo, so that it could potentially be used to treat the malignant head and neck carcinomas.
In the Checkmate-141 study project 361 patients were trialed and tested. These patients presented the chief complaints of suffering from either recurrent or metastatic squamous cell carcinoma of Head and neck (SCCHN). The cells that line the inner moist and mucosal surfaces of the head and neck are called as squamous cells. The cancer of head and neck usually begins with the abnormality in these cells. Therefore, the head and neck carcinoma may also be referred as squamous cell carcinoma of head and neck. All patients under study were in the advanced stages of their SCCHN cancer and also received a platinum-based chemotherapy within the last six months. Some of the patients received the therapy with a single drug Opdivo while some with other of the three standard chemotherapeutic options that were selected by the investigator e.g. docetaxel, cetuximab and methotrexate randomly. The comparative studies were done and the parameters like overall survival, progression free survival, safety and objective response rate were observed. As the results of the trials, it was observed that in the patients receiving Opdivo treatment there was an overall decrease of 30% in the death risk. The median overall survival was observed to be 7.5 months as compared to 5.1 months with the other choice drugs. The overall survival rate calculated for Opdivo for one year was 36% as compared to 16.6% with the other comparative control options. This data can be utilized in getting another approval for the use of the drug Opdivo, which is presently in use for treating lung cancer, melanoma and cancer of kidneys.
Nivolumab (Opdivo) is a PD-1 inhibitor drug. The programmed T-cell death-1 or PD-1 is a Trans membranous protein that is normally present on the T- cells surface. It binds to a ligand called PD-L1 that is expressed on tumor cells resulting in decreased cell mediated cytotoxicity and over all activity of T-Cells. This PD-1 and PDL-1 serve as the immunity checkpoints inside the body.
The Principal Investigator Dr. Maura Gillison, MD, PhD, Professor, Internal Medicine, College of Medicine of The Ohio State University observed an overall increase in survival among the patients that were treated with PD-1 inhibitors irrespective of the expression level of PD-L1 and status of Human Papillomavirus status (HPV). Dr. Gillison said that the most noticeable point in the study was an increase in proportion of cancer patients who lived up to a year. She further stated in an interview that from the results it was obvious that this study was proving to be beneficial for a group of patients suffering from this continuously worsening and fatal disease. According to her cancer can prove very devastating and fatal when it reoccurs and the survival in those patients was less than 6 months on average. “What’s got the field so excited is this tumor where we’re seeing a survival benefit is like the worst of the worst actors,” Gillison further said. In the earlier part of the meeting, researchers also demonstrated a data the patients with the advanced stage of melanoma, a form of skin carcinoma, when treated with Opdivo were still alive after a period of 5 years.
Meanwhile, in a research conducted by Bristol-Myers Squibb, the median overall survival observed was 9.1 months in patients Human papilloma virus (HPV) positive patients that were administered Opdivo, in comparison to 4.4 months for the other comparative options, However when the same study was conducted in the patients that negative for HPV, Overall survival with Opdivo was 7.5 months while with other choices was 5.8 months.