AstraZeneca has recently received two pivotal positive recommendations from the National Institute for Health and Care Excellence (NICE) for the use of their lung cancer treatments across England and Wales. These recommendations represent an important step forward in the treatment of lung cancer, offering hope to many patients suffering from this devastating disease. The two treatments receiving the recommendation are Tagrisso (osimertinib) for non-small cell lung cancer (NSCLC) and Imfinzi (durvalumab) for extensive-stage small cell lung cancer (ES-SCLC).
Tagrisso’s Positive Recommendation for Early-Stage Non-Small Cell Lung Cancer
The first of these treatments, Tagrisso, has received approval for use as an adjuvant treatment following complete tumor resection in patients with stage IB-IIIA NSCLC, whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions. The treatment is now recommended for routine use within the National Health Service (NHS) after successfully completing a three-year period within the Cancer Drugs Fund (CDF). This is a significant step forward, as it allows for osimertinib to be fully commissioned within NHS England, providing a much-needed option for patients who have undergone surgery to remove their tumors but face high recurrence risks.
The recommendation is based on the ADAURA Phase III trial, where osimertinib demonstrated outstanding results. The trial showed that adjuvant treatment with osimertinib reduced the relative risk of disease recurrence or death by 83% compared to placebo, with a disease-free survival rate of 90% for patients receiving Tagrisso, compared to just 44% for those who received a placebo. These results are groundbreaking, as they show the power of osimertinib in significantly improving the survival rates of patients with EGFR mutations, who are often at higher risk for recurrence after surgery.
Lung cancer remains the most common cause of cancer death in the UK, and NSCLC accounts for approximately 80-85% of lung cancer cases. A significant challenge in the management of NSCLC is the high recurrence rate, with as many as 30-50% of patients experiencing a relapse following surgery. The introduction of osimertinib as an adjuvant treatment represents a major advancement in the fight against this disease, offering patients a greater chance at long-term survival and improved outcomes post-surgery.
Imfinzi’s Positive Recommendation for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
The second treatment receiving a positive recommendation is Imfinzi (durvalumab), which has been approved for use in combination with etoposide and carboplatin or cisplatin for the treatment of untreated extensive-stage small cell lung cancer (ES-SCLC) in adults. This recommendation follows the success of the CASPIAN Phase III trial, which demonstrated the efficacy of durvalumab in combination with chemotherapy in patients with ES-SCLC.
SCLC is a highly aggressive form of lung cancer that progresses rapidly and often recurs. In extensive-stage SCLC, the cancer has spread beyond the lungs to other parts of the body, making it more difficult to treat. Prior to this recommendation, treatment options for ES-SCLC were limited, and the prognosis for patients was extremely poor. With fewer than 5% of patients surviving beyond two years, the positive data from the CASPIAN trial marks an important breakthrough in the treatment of SCLC.
The CASPIAN Phase III trial results showed that first-line treatment with durvalumab in combination with platinum chemotherapy significantly improved overall survival (OS) in patients with ES-SCLC. The hazard ratio for overall survival was 0.73 (95% confidence interval: 0.59-0.91; p=0.0047), meaning that patients receiving the combination treatment had a 27% reduced risk of death compared to those receiving chemotherapy alone. Updated results from the trial presented in 2021 further demonstrated that at three years, durvalumab plus chemotherapy reduced the risk of death by 29%, with a median overall survival of 12.9 months compared to 10.5 months for chemotherapy alone.
These results highlight the potential of durvalumab to significantly improve outcomes for patients with ES-SCLC, a disease that has historically had few treatment options and a poor prognosis. For SCLC patients, this combination treatment offers a much-needed advancement, providing a chance for improved survival and quality of life.
Challenges in Lung Cancer Treatment
Lung cancer, particularly SCLC and NSCLC, presents unique challenges for treatment due to the aggressive nature of these cancers and their tendency to spread rapidly to other parts of the body. In the case of NSCLC, which is the most common type of lung cancer, EGFR mutations are present in about 12% of patients. These mutations make the cancer more susceptible to targeted treatments like osimertinib, but the risk of recurrence after surgery remains high. The introduction of osimertinib as an adjuvant treatment for these patients is a welcome addition to the treatment landscape, offering patients the potential for better long-term survival outcomes.
On the other hand, SCLC is known for its rapid progression and high recurrence rate, making treatment particularly challenging. The combination of durvalumab with chemotherapy represents a significant breakthrough in the management of ES-SCLC, offering clinicians a powerful tool to improve survival rates in a patient population that has historically had limited treatment options.
Impact of NICE Recommendations
The NICE recommendations for Tagrisso and Imfinzi are expected to have a significant impact on the treatment of lung cancer in the UK. These positive recommendations will allow both treatments to be used routinely within the NHS, ensuring that a wider range of patients have access to these innovative therapies. This is an important milestone for patients with NSCLC and ES-SCLC, as it provides them with better treatment options and the possibility of improved outcomes.
AstraZeneca’s Commitment to Lung Cancer Treatment
AstraZeneca’s commitment to advancing lung cancer treatment is evident in the positive recommendations from NICE. The company has a long-standing focus on developing innovative therapies for cancer patients, and these latest recommendations are a testament to the success of their research and development efforts. Since 2021, AstraZeneca has received 28 positive recommendations from NICE and the Scottish Medicines Consortium (SMC) across multiple cancer types and stages, further solidifying its position as a leader in the fight against cancer.
Tom Keith-Roach, President of AstraZeneca UK, expressed his pride in the positive decisions by NICE, stating, “This is fantastic news for lung cancer patients. We are proud that these decisions by NICE mean we’ve had 28 positive recommendations by NICE and the SMC since 2021 across multiple cancer types and stages. This represents another step towards our bold ambition to one day eliminate cancer as a cause of death.”
The recent positive NICE recommendations for Tagrisso and Imfinzi mark a significant advancement in the treatment of lung cancer in the UK. These therapies offer hope for patients with NSCLC and ES-SCLC, two of the most challenging and aggressive types of lung cancer. The success of these treatments in clinical trials and the subsequent approval for NHS use will provide patients with improved survival rates and a better quality of life. As AstraZeneca continues to innovate in the field of cancer treatment, these recommendations bring us one step closer to the ultimate goal of eliminating cancer as a cause of death.
