Breakthrough treatment possible new mainstay against lung cancer
Immunotherapy drug outperforms chemo in latest trial
A recent study comparing the immunotherapy drug pembrolizumab to chemotherapy could alter more than 30 years of practice in lung cancer treatment.
The clinical trial, known as Keynote-024 (KN-024), showed pembrolizumab’s superiority in preventing cancer progression and prolonging the lives of previously untreated patients with non-small cell lung cancer (NSCLC).
“We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small cell lung cancer,” said Dr. Roger M. Perlmutter, president of MSD Research Laboratories. “We look forward to sharing these data with the medical community and with regulatory authorities around the world.”
Pembrolizumab boosts the immune system’s antitumor activity by preventing cancer cells from interacting with the immune system’s T-cells. During interaction, tumor cells produce a protein called the Programmed Death-Ligand 1 (PD-L1) which deactivates T-cells. Blocking this enables T-cells to remain capable of detecting and destroying cancer in the body.
The Philippine Food and Drug Administration (FDA) approved pembrolizumab for the treatment of advanced melanoma and PD-L1-positive lung cancer that failed previous therapies. Immuno-oncology leader MSD introduced this breakthrough anti-cancer drug in the Philippines last March.
Consistent results on safety and efficacy
KN-024 is a randomized study with 305 participants who received either pembrolizumab or chemotherapy. When it demonstrated the new drug’s efficacy in halting the progress of cancer and increasing survival rates, an independent Data Monitoring Committee (DMC) recommended an end to the trial. The DMC further recommended that patients on chemotherapy be given the opportunity to receive pembrolizumab.
The results also showed that the drug was consistent in terms of safety and tolerability, with side effects commonly immune-mediated, or due to the response of the immune system. Only less than five percent of participants experienced these adverse effects during the study.
In case of a severe reaction to the drug, doctors advise stopping treatment temporarily and taking steroids to alleviate the side effects. Treatment may resume once the patient’s condition improves.
A game-changer in cancer treatment
According to Globocan 2012, lung cancer is the top cause of cancer mortality worldwide, accounting for 1.5 million deaths annually. In the Philippines, doctors report over 12,000 new cases of lung cancer each year and more 10,000 deaths due to the disease.
With immunotherapy possibly becoming the new standard of lung cancer treatment, millions of patients can now hope for better chances of survival while being spared from the harsh effects of existing treatment options.
MSD will present the results of the KN-024 trial in an upcoming medical meeting.
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KEYNOTE-024 is a randomized, pivotal,phase 3 study (ClinicalTrials.gov, NCT02142738) evaluating pembrolizumabmonotherapy compared to standard of care(SOC) platinum-based chemotherapies in the treatment of patients with advanced NSCLC. Patients enrolled were those who had received no prior systemic chemotherapy treatment for their advanced disease and whose tumors expressed high levels of PD-L1 (defined as a tumor proportion score of 50 percent or more) as determined by a central laboratory using an immunohistochemistry assay. The study randomized 305 patients to receive pembrolizumab(200 mg every three weeks) or SOC platinum-based chemotherapies: paclitaxel+carboplatin, pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+carboplatin, or gemcitabine+cisplatin. Pemetrexed maintenance therapy was permitted for patients with non-squamous histologies. In addition, patients randomized to the control had the option of crossing over to pembrolizumab upon disease progression. The primary endpointis PFS; secondary endpoints are OS and overall response rate (ORR).
For 125 years, MSD has been a global health care leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., Kenilworth, N.J., USA. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.com.