According to AstraZeneca, the FDA authorized the medicine based on the Phase III POSEIDON research findings. Patients with a maximum of five cycles of the anti-CTLA-4 antibody IMJUDO, followed by four cycles of IMFINZI and four cycles of platinum-based chemotherapy, had a 23% lower risk of death.
33% of patients with a greater survival rate after treatment were alive two years later, compared to 22%. Furthermore, the risk of disease progression or mortality was reduced by 28% compared to chemotherapy alone.
According to the Centers for Disease Control and Prevention, lung cancer is the third most frequent cancer in the United States and has the highest fatality rate. Small cell lung cancer (SCLC) affects around 20% of patients with lung cancer, while the vast majority have non-small cell lung cancer (NSCLC) (NSCLC).
Between 1990 and 2002, total mortality from the illness dropped by 56% in men and 32% in women, albeit both remain incredibly high. The FDA authorized AstraZeneca’s IMFINZI (durvalumab) in combination with IMJUDO (tremelimumab) and platinum-based chemotherapy in December 2016 for the treatment of Stage IV (metastatic) non-small cell lung cancer (NSCLC).
The POSEIDON Phase III research indicated a consistent survival advantage, increasing overall survival (OS) by 25% compared to chemotherapy alone after nearly four years of follow-up, according to findings presented at the ESMO Congress 2022 and published in the Journal of Clinical Oncology.
Individuals treated with the combo had a 25% 3-year survival rate, much better than the 13.6 percent survival rate for patients treated with chemotherapy alone. The safety profile of IMJUDO in combination with IMFINZI and chemotherapy was identical to the individual pharmaceutical safety profiles, indicating no additional safety signals.
With about 236,000 new cases identified that year, lung cancer will be the second most frequent illness in the United States. Only around 8% of persons with metastatic non-small cell lung cancer survive more than five years following diagnosis, which is a dismal prognosis. 2
“Since many patients’ tumors do not respond well to standard therapies such as checkpoint inhibitors, metastatic non-small cell lung cancer is challenging to treat, “Melissa Johnson, MD, the POSEIDON Phase III trial’s principal investigator and Director of Lung Cancer Research at Tennessee Oncology’s Sarah Cannon Research Institute, stated.
With the approval of a combination immunotherapy regimen that includes chemotherapy and CTLA-4 inhibition, patients suffering from this horrible disease now have a new, often well-tolerated treatment option.
According to Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, “This green light emphasizes the importance of developing novel treatment combinations that improve survival in the complex setting of metastatic non-small cell lung cancer, where many patients still face a bleak prognosis.
This is the second indication for IMJUDO added to IMFINZI in as many weeks after its approval in unresectable liver cancer, highlighting our commitment to improving patient outcomes in cancer settings with continuing unmet needs. Based on the POSEIDON results, several other nations, including Europe and Japan, are actively considering regulatory applications for this indication.
Because of the PACIFIC Phase III research results, IMFINZI is the only immunotherapy approved for use in patients with unresectable Stage III NSCLC whose disease has not progressed following chemoradiation treatment. Evidence from the CASPIAN Phase III research was used to get clearance for IMFINZI to treat patients with advanced-stage small-cell lung cancer in many countries (ES-SCLC).
The TOPAZ-1 Phase III trial evidence supported IMFINZI’s approval in the United States and several other countries for use in combination with chemotherapy to treat locally advanced or metastatic biliary tract cancer, and the HIMALAYA trial evidence supported IMFINZI’s approval in the United States for use in combination with IMJUDO to treat unresectable hepatocellular carcinoma.