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Immuno oncology duo Bristol Myers Squibb’s Opdivo and Yervoy is working hard to push its way forward with regulatory approvals in lung cancer.
The FDA greenlighted the pair alongside two cycles of platinum chemo for the treatment of non-small cell lung cancer last week.
The drugs were given the go-ahead for first-line patients without EGFR or ALK mutations.
The news comes just 11 days after the FDA cleared Opdivo and Yervoy for use sans chemo in PD-L1-positive patients. The therapy has been approved for patients with squamous or non-squamous disease.
The recent approvals were based on findings from the CheckMate-227 trial, in which the combination of drugs demonstrated a significant improval in survival rates compared to chemotherapy alone.
Median survival was 14.1 months for the combo, versus 10.7 months for chemo alone. While a sans-chemo regimen has proved successful in helping patients to get treatment without harmful chemo side effects, experts have remained focused on the platinum chemo’s potential.
Bristol Myers Squibb has hoped for a ‘fast initial response’ to chemo alongside the ‘durable longer-term benefits to patients. Wolfe Research analyst Tim Anderson said the company had already shown its ability.
In a note to clients back in October, Anderson wrote: “Chemotherapy, when given to lung cancer patients, often shows a fast initial response, but one that lacks durability.
“But by combining chemotherapy+Opdivo+Yervoy, BMY may have (finally) found a cocktail of drugs that delivers both near- and longer-term benefit, leading to an early response and improved long-term survival.”
General manager and head of US Oncology, Immunology, Cardiovascular at Bristol Myers Squibb Adam Lenkowsky noted that non-small cell lung cancer is difficult to treat and typically needs multiple options to address the needs of different patients.
He said: “This second approval of an Opdivo and Yervoy-based combination for the first-line treatment of advanced NSCLC now gives more patients access to a dual immunotherapy approach that can be administered with or without limited chemotherapy, depending on the patient and their PD-L1 status, and the possibility of a chance to live longer.”
Opdivo, Yervoy and chemo have since cut patient’s risk of death by a huge 31%, with a minimum follow-up of 8.1 months.
Those figures improved with longer follow up – at the 12.7 month mark, patient death risk was down by 38% in patients with PD-L1 levels below 1%. The death risk in patients with PD-L1 levels of 1% or more dropped by 36%.
Despite being cleared by the FDA, BMS still has a huge challenge ahead – stealing share from Merck’s chemo combo. The company’s Keytruda has been highly successful over the last three years, showing its potential to cut patient death risk by 51%.
Over the last decade, new lung cancer diagnoses have dropped by 19% in the US.
BMS may also have to address side effects from its combo, though the extent of the side effects is not yet known. CureToday reported the most common side effects of the combo were rash, diarrhea/colitis, decreased appetite, fatigue, difficulty breathing, nausea, hepatitis, and severe itching.
Anderson wrote: “Opdivo plus Yervoy by itself shows toxicity, and adding chemotherapy into the mix will only increase this. The commercial value of CM-9LA will therefore depend on the balance between the clinical benefit and the toxicity. It will only be once full results are presented” that a risk-benefit assessment “will be possible.”
Lead investigator in the CheckMate study David P. Carbone said researchers have come a long way in understanding how to use dual immunotherapy to treat cancer patients.
He added: “The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.”