Sotorasib Is Indicated As Monotherapy For The Treatment Of Adult Patients With KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed On, Or Are Intolerant To, Platinum-Based Chemotherapy And/Or Anti PD-1/PD-L1 Immunotherapy. 1
KRAS G12C Gene Mutation Is Found In Around 1 In 8 Patients With NSCLC 2
CAMBRIDGE, UK – (3rd March 2022) – The National Institute for Health and Care Excellence (NICE) has today published a final appraisal document recommending Lumykras™ (sotorasib) for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy, in accordance with the managed access agreement.1,4,15
Amgen’s first-in-class drug, Sotorasib, was the first new medicine to receive a Conditional Marketing Authorisation* from the Medicines and Healthcare products Regulatory Agency (MHRA) for use across England, Scotland and Wales under Project Orbis.4,5 The treatment, an oral targeted therapy, will now be available to suitable patients in England via the Cancer Drugs Fund, addressing an unmet need in previously treated patients with KRAS G12C NSCLC, a mutation which was previously thought to be “undruggable”.4,5
Lung cancer is the third most common cancer with an estimated 48,000 new cases diagnosed in the UK ever year.7 NSCLC accounts for 85% of lung cancers and approximately 13% of these are thought to have the KRAS G12C mutation.2,6 Sotorasib represents a new treatment option for suitable patients who have had biomarker testing and been identified with this mutation.1,5
Professor Sanjay Popat, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust said: “Sotorasib is a step change for these patients, allowing them to receive daily tablets rather than chemotherapy in the hospital. I’m therefore delighted NICE has approved this drug for patients via the Cancer Drug Fund. Importantly, in parallel the NHS is making excellent progress in molecular analysis of lung cancer patients to find the KRAS G12C mutation and identify those patients who are most likely to benefit from this treatment.”
Dr. Tony Patrikios, Executive Medical Director at Amgen UK and Ireland said: “Sotorasib provides a new treatment option for appropriate patients whose lung cancer is found to have the KRAS G12C mutation. More than half of NSCLC patients have advanced or metastatic disease at diagnosis and outcomes across the UK remain poor7. Amgen is proud of our collaboration with both NHS England and NICE to ensure people living with NSCLC who may benefit from sotorasib can access the medicine without delay.”
Paula Chadwick, Chief Executive of Roy Castle Lung Cancer Foundation said: “This recommendation demonstrates all the hard work that is happening to develop new treatment options for people with lung cancer. The pandemic has had a devastating effect on these patients, potentially denying many of them the chance of an earlier, and possibly life-saving diagnosis. However, the advances in new treatments like sotorasib offer some hope by giving people another treatment option.”
The NICE decision to recommend sotorasib for use in the Cancer Drugs Fund follows an agreement between Amgen and NHS England which has already enabled more than 100 patients to access the medicine following its Conditional Marketing Authorisation by MHRA via Project Orbis.5
The Conditional Marketing Authorisation for sotorasib is based on clinical evidence from the Phase 2 CodeBreaK 100 study which evaluated the drug in 126 patients with KRAS G12C-mutated advanced NSCLC.8 This trial demonstrated an Objective Response Rate ORR (primary end point) of 37.1% (95% confidence interval [CI], 28.6 to 46.2)8, and an Overall Survival OS (secondary end point) of 12.5 months (95% CI, 10.0 to not evaluable)8. Among 46 patients with ORR, the median Duration of Response (DoR) was 10.0 months (95% CI, 1.2 to 11.1). 1
The most common adverse reactions observed with sotorasib were diarrhoea (34%), musculoskeletal pain (31%), nausea (25%), fatigue (21%), hepatotoxicity (19%) and cough (16%). The most common severe (grade ≥ 3) adverse reactions were increased ALT (5%), increased AST (4%), and diarrhoea (4%). The most common adverse reactions leading to permanent discontinuation of treatment were increased ALT (1%), increased AST (1%) and drug-induced liver injury (1%). The most common adverse reactions leading to dose modification were increased ALT (6%), increased AST (6%), and diarrhoea (6%).1
*This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited.
NOTES TO EDITORS
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, a KRAS G12C inhibitor. 3,10 Sotorasib was the first KRAS G12C inhibitor to enter the clinic and is being studied in 10 combinations with global sites spanning four continents.11 In just under three years, the CodeBreaK clinical development programme for sotorasib has established a clinical data set with more than 800 patients studied across 13 tumour types to date.12
More information about sotorasib can be found in the Summary of Product Characteristics. 1
The CodeBreaK clinical development programme is designed to study the risk benefit associated with Amgen’s investigational drug sotorasib for patients with an advanced solid tumour with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.9,13
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicentre single arm study, enrolled patients with KRAS G12C-mutant solid tumours.9 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed Objective Response Rate (ORR).9 ORR by blinded Independent Review Committee. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST 1.1 at baseline.8,14
A global Phase 3 randomised active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK) includes sites across the UK.13
About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that aim to advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.
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Name: Tom Cook
Telephone: +44 (0) 1895 525014
Name: Rosanna Forrest (Analogy)
Telephone: +44 (0) 7714 755742
References1. Amgen. LUMYKRAS Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/12871. Accessed March 2022.
Job code: UKI-510-0222-00002
Date of Preparation: March 2022