Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Opdivo (nivolumab) plus chemotherapy to treat a type of non-small cell lung cancer (NSCLC).
Opdivo (360mg intravenous injection), in combination with platinum-doublet chemotherapy, was indicated for neoadjuvant treatment of resectable NSCLC, regardless of PD-L1 status, said the company.
The drug was previously approved, in combination or as a standalone therapy, by regulatory agencies in various countries, to treat several types of cancers.
The indications include lung cancer, kidney cancer, head and neck cancer, urothelial cancer, colon cancer, oesophageal cancer, liver cancer, and gastric cancer, among others.
The US agency approved the company’s application under its Real-Time Oncology Review (RTOR) pilot programme, which aims to enable rapid approval of effective treatments.
Also, the review was conducted under the FDA’s Project Orbis initiative, which enabled simultaneous review by the health authorities in Australia, Canada and the UK.
Bristol Myers Squibb US cardiovascular, immunology and oncology senior vice president and general manager Adam Lenkowsky said: “At Bristol Myers Squibb, we are leading innovative science in the use of immunotherapy in earlier stages of cancer and are committed to bringing these options to patients.
“Today’s approval builds on that commitment and expands the role of Opdivo-based treatment in NSCLC, the most common form of lung cancer, so patients may benefit earlier in the course of their disease.”
The FDA approval is supported by positive results from Phase 3 CheckMate -816 trial of Opdivo plus platinum-doublet chemotherapy compared to chemotherapy alone.
The study excluded patients with unresectable NSCLC, known EGFR mutations or ALK translocations, Grade 2 or greater peripheral neuropathy, active autoimmune disease, or those who require systemic immunosuppression.
Event-free survival (EFS) and pathologic complete response (pCR) include the primary endpoints, while overall survival (OS) is an additional efficacy outcome measure.
In the trial, Opdivo plus chemotherapy showed a statistically significant improvement in EFS, reducing 37% risk of progression, recurrence or death, compared to chemotherapy alone.
The combination showed a median EFS of 31.6 months compared to 20.8 months for patients treated with chemotherapy alone.
In addition, 24% of patients treated with Opdivo plus chemotherapy achieved pCR, compared to 2.2% of patients treated with chemotherapy alone.
The most common adverse reactions observed in the study include nausea, constipation, fatigue, decreased appetite, and rash.
CheckMate -816 study investigator Mark Awad said: “Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning.
“The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery.
“Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”
