In the world of mesothelioma research, there are both unexpected victories and devastating disappointments, and sometimes those disparate results can occur while examining the same treatment protocol. An example of this was seen recently in the Lume-Meso study of a new medication, the kinase inhibitor nintedanib. Nintedanib had previously delivered highly promising results in a phase 2 trial that combined it with the standard mesothelioma chemotherapy treatment of pemetrexed/cisplatin. Unfortunately, a report delivered during the International Association for the Study of Lung Cancer’s 19th World Conference on Lung Cancer revealed that once the study had moved on to the protocols involving a larger group of participants, the previous results were contradicted, with scientists involved finding that the combination of medications provided none of the survival benefit that had previously been seen.
In understanding the impact of the different mesothelioma trials, it is important to recognize the difference between a Phase 2 and Phase 3 study. Phase 2 trials have the mission of determining whether a treatment protocol works, and is usually tested on groups ranging from 25 to 100 patient participants. No placebo is used. By contrast, Phase 3 trials compare the treatment against existing treatments to determine whether it provides any additional benefit. They involve more participants and last longer. In the case of this trial, 458 patients diagnosed with the epithelioid subtype of malignant pleural mesothelioma were assigned to receive pemetrexed/cisplatin on day 1 and either nintedanib or a placebo on day 2. The results revealed no meaningful clinical improvement in progression-free survival or overall survival using nintedanib.
Speaking of the results found in the mesothelioma trial, the study’s lead researcher, Giorgio Scagliotti, MD, PhD, of the University of Turin, Italy, said, “Unfortunately, the phase 3 results of LUME-Meso did not confirm that nintedanib in combination with pemetrexed/cisplatin prolongs patients’ lives … However, the trial reaffirms the need for solid confirmatory studies that are adequately sized, to challenge the standard of care in advanced malignant mesothelioma.”
Despite the disappointment of these results, there are many more clinical trials offering great promise for mesothelioma patients. If you or someone you love has been diagnosed with this rare form of cancer and you need information or any other type of assistance, we are here to help. Contact us at 1-800-966-2244 to learn more.