MSD’s anti-PD1 drug, Keytruda (pembrolizumab), has become the cancer immunotherapy treatment with the most indications funded by the National Health System (SNS), with a total of 17 indications. The latest milestone for this drug has been the first approval in Europe of an anti-PD-1/L1 therapy in resectable non-small cell lung cancer (NSCLC). The medical director of MSD, Joaquin Mateosexplains to EG the importance of this approval and the lines of research where immunotherapy is headed.
Ask. Recently, the EMA has approved pembrolizumab plus chemotherapy as neoadjuvant treatment and then as monotherapy in adjuvant treatment for resectable NSCLC with a high risk of recurrence in adults. What does this approval mean for the treatment of lung cancer?
Answer. First of all, it is important to emphasize that in our country there is still no approval for the financing of this indication. At MSD we work with a firm commitment to developing therapeutic solutions against cancer that improve the quality of life of patients and, to the extent possible, also extend their lives. Thanks to advances like this, the long survival of lung cancer patients is already a reality in many cases. Additionally, pembrolizumab is a type of immunotherapy that has been shown to be effective in several types of cancer, and its use in non-small cell lung cancer is particularly promising. In this sense, another of the characteristics that makes this approval so important is that the treatment is effective regardless of the expression of PD-L1, which means that the range of patients who can obtain positive results with it is much broader. .
Q. What were the results of phase 3 KEYNOTE-671?
A. With a median follow-up of 36 months, neoadjuvant treatment with pembrolizumab plus chemotherapy, followed by pembrolizumab monotherapy after surgery, significantly improved overall survival in patients with resectable stage II, IIIA, or IIIB NSCLC. This approach significantly reduced the risk of death by 28 percent compared with neoadjuvant treatment of placebo plus chemotherapy, followed by placebo as monotherapy after surgery, regardless of PD-L1 expression. The pembrolizumab-based regimen also increased median event-free survival by nearly two and a half years compared with patients receiving chemotherapy and placebo alone. We believe that the impact of these findings is significant for the medical community and for patients. Traditionally, resectable NSCLC in advanced stages has been one of the most difficult forms of lung tumor to treat, with high recurrence and mortality rates.. The introduction of pembrolizumab in patient management as a neoadjuvant and adjuvant treatment offers a new therapeutic strategy that not only attacks cancer more effectively, but also improves patients’ quality of life by reducing the need for additional treatments and potentially more invasive in the future.
“Despite clinical advances for patients with metastatic lung cancer, it remains the leading cause of cancer death in Europe”
Q. What are the unmet needs in the treatment of lung cancer?
A. Despite clinical advances for patients with metastatic lung cancer, it remains the leading cause of cancer death in Europe. This statistic underscores the critical importance of addressing the disease in its earliest stages, where treatment can be more effective, improving prognosis and allowing us to talk about long survival as a reality. In the early stages, lung cancer is generally more localized and susceptible to effective interventions, such as surgery, radiotherapy and chemotherapy. Intervening before cancer spreads can significantly improve survival rates and patients’ quality of life. Additionally, treating lung cancer early may reduce the need for more aggressive and extensive treatments in the future. This not only decreases the burden of disease on the patient, but can also reduce the cost of long-term healthcare and free up resources for other areas of need in the healthcare system, ensuring its sustainability.
Q. Currently, it is the immunotherapy treatment for cancer with the most indications funded by the SNS. What new indications are under investigation for pembrolizumab?
A. Currently, MSD has a robust clinical research program in immuno-oncology with more than 1,600 clinical trials. Of these, 120 trials are being carried out in Spain with the participation of more than 1,800 patients. Since the first indication for melanoma was achieved in 2015, our team has dedicated its efforts to translating research results into real solutions for patients. However, it is difficult to predict what the next indication to be approved may be since there are numerous ongoing investigations. What we will see from MSD in the short term will be, on the occasion of ASCO 2024, the presentation of promising data in research with regimens based on pembrolizumab or in combination for pathologies such as advanced bile duct cancer, gastric cancer or HER-2 negative advanced gastroesophageal junction, or previously untreated locally advanced or metastatic urothelial cancer, among others.
“At MSD we believe that the key to oncological research lies in collaboration. “Joining efforts with the pharmaceutical industry, the scientific community, the Administration, and thanks to the generosity of patients, associations, and their families and caregivers”
Q. Where are the lines of research in immunotherapy heading?
A. Currently, immunotherapy research is experiencing truly exciting expansion in several directions. We are seeing significant advances in key areas that are redefining the way we approach cancer treatment. At MSD we are studying our PD-1 inhibitor, pembrolizumab, in approximately 20 ongoing registration studies in multiple cancer types in these early stages. Our goal is to offer more therapeutic alternatives to patients, since early detection can significantly increase the chances of survival. In this sense, at MSD we believe that the key to oncological research lies in collaboration. By joining forces with the pharmaceutical industry, the scientific community, the Administration, and thanks to the generosity of patients, associations, and their families and caregivers, we are able to jointly carry out new clinical studies that evaluate the combination of different medications in different indications and types of tumors.
“In this time we have also delved into how this therapy is not only useful in metastatic phases, but it is also possible to achieve important results in more initial stages of tumor development”
Q. Since the first approval of pembrolizumab in 2015, how has knowledge of anti-PD-1 agents improved?
A. The initial approval of pembrolizumab marked a milestone in cancer immunotherapy. Since then, our knowledge about this class of drugs has grown exponentially. During this time we have also delved into how this therapy is not only useful in metastatic phases, but it is also possible to achieve important results in more initial stages of tumor development. Thanks to multiple trials, we have identified the promising results of pembrolizumab when the disease is still in its initial stages, which places us in a scenario in which the prognosis of the disease is much more favorable and the possibilities of an improvement in the recovery are increased. quality of life and greater survival. Precision medicine in this area is decisive. It has allowed us to identify predictive biomarkers such as PD-L1 expression and microsatellite instability, which allow us to direct treatment much more specifically to those tumors whose characteristics point to a much more effective response. And of course, with more clinical experience, we have improved the management of pembrolizumab-related side effects, such as autoimmune reactions.
Q. What are the next challenges for MSD in Oncology?
A. As I have already mentioned, our main objective is to continue researching to make innovative therapeutic solutions available to more and more professionals and patients. Our commitment is to provide more treatment alternatives to patients, improve their quality of life and boost long survival rates through the detection and therapeutic approach to cancer in early stages. The research carried out in recent years has allowed us to understand much better all the mechanisms that underlie the development of this disease. This has led to the development of precision medicine, which seeks to administer the most appropriate treatment based on the characteristics of each tumor and the genetics of each person. This is a key area for MSD. Looking ahead, we are not just limited to immuno-oncology. We are actively exploring other promising avenues of research that allow us to transform science into facts, thereby improving patient outcomes and quality of life.
