Bristol Myers Squibb's immunotherapy Opdivo not only extends survival in patients with a certain type of head and neck cancer but data, presented at the European Society of Medical Oncology congress, also show improvements on quality of life measures.
Patient-reported quality-of-life data from the pivotal Phase III CheckMate -141 trial show that, compared to treatment with investigator's choice of methotrexate, docetaxel or cetuximab, Opdivo stabilised symptoms and functioning - including physical, role and social functioning across three separate instruments - in patients with squamous cell carcinoma of the head and neck.
Both patients expressing PD-L1 and those who didn't given the investigator's choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo, the firm said.
In addition, Opdivo more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea and insomnia, compared to investigator's choice of therapy.
"Patients living with this form of advanced head and neck cancer often experience debilitating physiological effects as well as emotional and social challenges brought on by the condition despite current treatment options," said Kevin Harrington, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London.
"These patient-reported outcomes are encouraging, as they help us understand the potential for Opdivo to impact important quality-of-life measures for this patient population."
The drug is currently under review for this indication on both sides of the Atlantic, on the back of data from the Phase III CheckMate -141 trial, that evaluated overall survival in patients with SCCHN taking Opdivo after platinum therapy compared to investigator's choice of therapy.
A first look at the data from study, stopped early in January 2016 after meeting its primary endpoint of overall survival, showed that patients treated with Opdivo experienced a 30 percent reduction in the risk of death compared to the investigator's choice of therapy, with a median overall survival of 7.5 months versus to 5.1 months.
Also at ESMO, BMS presented data from the Checkmate -275 trial showing an overall response rate of 19.6 percent in all previously treated patients with bladder cancer who received Opdivo.
Responses were observed in both PD-L1 expressors and non-expressors, with the confirmed objective response rate in those expressing PD-L1 ≥1 percent 23.8 percent and in those expressing <1 percent 16.1 percent.
For patients expressing PD-L1 ≥5 percent the confirmed ORR was 28.4 percent, and 15.8 percent in those expressing <5 percent, BMS said.
"The prognosis for patients with metastatic urothelial carcinoma progressing despite platinum-based chemotherapy is poor, and treatment options have historically been quite limited," said Matthew Galsky, professor of medicine and director of Genitourinary Medical Oncology, The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai.
"In the CheckMate -275 study, we observe that with Opdivo, patients who responded experienced rapid and durable responses, including patients with PD-L1 expressing and non-expressing tumours. These results are encouraging," he said.
The company has already filed data on checkpoint inhibitor in this setting, which is being reviewed by regulators.
On negative note, BMS also unveiled further data on Opdivo primary analysis of CheckMate -026, a trial investigating the use of the drug monotherapy as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) whose tumours expressed PD-L1 ≥1 percent.
The study did not meet the primary endpoint of superior progression-free survival compared to chemotherapy. In patients with ≥5 percent PD-L1 expression, the median PFS was 4.2 months with Opdivo and 5.9 months with platinum-based doublet chemotherapy .
Overall survival was 14.4 months for Opdivo versus 13.2 months for chemotherapy.
"The CheckMate-026 trial results strengthen our belief that the majority of previously untreated NSCLC patients may require combination therapy in order to experience an improved benefit versus chemotherapy," said Fouad Namouni, head of development, Oncology, BMS.
The firm is also exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.
The drug is already approved for both metastatic squamous and non-squamous NSCLC patient populations, after a prior therapy, and updated results from two pivotal Phase III studies, CheckMate-057 and CheckMate -017, presented at ESMO show that more than one-third of previously treated patients in both trials experienced ongoing responses with Opdivo, compared to no ongoing responses in the docetaxel arm.
The median duration of response with Opdivo versus docetaxel in CheckMate -057 was 17.2 months and 5.6 months, respectively, and in CheckMate -017 it was 25.2 months versus 8.4 months. Also, in both studies, durability of response was observed in both PD-L1 expressors and non-expressors, the firm noted.
Also at ESMO, BMA showed updated data revealing an overall response rate of 40.4 percent in patients with metastatic renal cell carcinoma taking a combination of Opdivo and Yervoy (ipilimumab) after two years' follow-up.
"There remains a significant unmet need for treatment options that offer ongoing responses and increase survival for patients with renal cell carcinoma, the most common type of kidney cancer," said Asim Amin, Levine Cancer Institute, Carolinas HealthCare System. "The results from CheckMate -016 are encouraging and warrant further study".