The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node-positive) non-small cell lung cancer (NSCLC) in adults.
Over 4,800 patients could be eligible to receive the immunotherapy-chemotherapy combination prior to surgery.
The decision follows an expedited regulatory license approval via Project Orbis, a programme coordinated by the Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) to review and approve promising cancer drugs, helping patients access treatments faster.
The immunotherapy-chemotherapy combination also saw an expedited review through NICE’s proportional approach to technology appraisals (PATT) process, allowing BMS to provide the treatment to patients at least two months sooner than under routine NICE approval processes.
“Being diagnosed with lung cancer is incredibly traumatic,” said Paula Chadwick, Chief Executive of Roy Castle Lung Cancer Foundation. “Being told it has returned after undergoing curative-intent treatment is nothing short of devastating, so we are delighted that treatments to reduce the risk of recurrence are
being made available to people with early-stage NSCLC before surgery and with it the hope that improved outcomes are possible.”
“Following surgery, many patients are not fit enough for further medical treatment to help reduce the risk of cancer returning,” said Dr Riyaz Shah, Consultant Medical Oncologist, Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, and member of the British Thoracic Oncology Group Steering Committee. “Today’s approval is a milestone in the treatment of resectable NSCLC, which will allow me to offer an earlier treatment option to patients before they receive surgery, potentially improving their quality of life and outcomes following surgery.”
The decision is supported by data from the Phase 3 CheckMate –816 trial, which compared nivolumab plus platinum doublet chemotherapy with platinum doublet chemotherapy alone in adults with stage 1B to 3A resectable NSCLC (American Joint Committee on Cancer [AJCC]/Union for International Cancer Control (UICC] seventh edition).
Within the trial, patients with resectable NSCLC, receiving neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival than in chemotherapy alone; 31.6 months (95% CI 30.2 to not reached) and 20.8 months (95% CI 14.0 to 26.7) respectively (hazard ratio for disease progression, disease recurrence, or death, 0.63). There was also a higher percentage of patients with a pathological complete response: 24.0% (95% CI, 18.0 to 31.0) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P<0.001).5 The incidence of grade 3 or 4 treatment-related adverse events was 33.5% in the immunotherapy plus chemotherapy group and 36.9% in the chemotherapy alone group.
Nearly 42,000 people are diagnosed with lung cancer in England and Wales every year (2016-2018). Lung cancer is the leading cause of cancer deaths in the UK, accounting for 21% of all cancer deaths (2017-2019).
NSCLC is the most common type of lung cancer, accounting for around 80-85% of all lung cancer cases. Surgery is the standard care for resectable NSCLC, however up to 55% of patients who undergo curative surgery have recurrence and ultimately die of the disease. “Bristol Myers Squibb is committed to providing innovative medicines to patients with difficult-to-treat cancers,” said Scott Cooke, General Manager, UK and Ireland at Bristol Myers Squibb. “We are delighted that by working collaboratively with the MHRA and NICE, eligible patients in England and Wales will have access to another treatment option.”
Source: Bristol Myers Squibb
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