By Jennifer C. King, PhD, Director of Science & Research
This weekend at a major medical conference in Denmark some of the highly anticipated research studies about immunotherapy in lung cancer were presented for the first time.
Leading the news was the KEYNOTE-024 clinical trial that looked at Keytruda (pembrolizumab) given to patients with metastatic non-small cell lung cancer (NSCLC) in the “first-line setting” — meaning before patients had taken another therapy. To take part in the trial, patients had to have biomarker testing (also known as molecular testing) and have a high score (>50%) for a biomarker known as PD-L1. Then they were randomly chosen to receive standard-of-care chemotherapy or Keytruda.
The results (which were simultaneously published in the New England Journal of Medicine) showed that patients who took Keytruda had a better response rate (44.8% vs 27.8%) and the median time on the treatment before cancer progressed was four months longer. There was also an increase in the percent of people surviving at six months (80% vs 72%) in the Keytruda group, although it is too early to report the average overall survival for the two groups. Notably, the rate of severe side effects was also lower in the Keytruda group compared to chemotherapy.
UPDATE: Keytruda is now approved as an option for patients with advanced non-small cell lung cancer in the first line setting who show a 50% or greater expression of PD-L1! Learn more.
Take home point: The Food and Drug Administration (FDA) is currently reviewing this data, but it is likely we will see Keytruda as a new option for patients with newly-diagnosed metastatic lung cancer very soon. It is important for patients to get biomarker testing up-front at diagnosis to help them choose the most appropriate treatment option for their cancer.
There was also additional Keytruda data presented showing that a combination of chemotherapy and Keytruda first-line may benefit more patients, not just those who have a high PD-L1 biomarker score. 55% of non-squamous NSCLC patients responded to the combination, compared to 26% responding to chemotherapy alone. Phase 3 clinical trials are currently enrolling (for both non-squamous and squamous NSCLC) to definitively show this difference. Many combinations of immunotherapies and different types of drugs (chemo, radiation, other immunotherapies, targeted therapies) are actively under investigation in clinical trials.
The other approved anti PD-1 immunotherapy for lung cancer, Opdivo, did not fare so well in its first-line trial. In this trial, a broader group of people were considered eligible–there wasn’t as high a cut off on the PD-L1 biomarker level. There were also some different response criteria used and the immunotherapy group had more patients with liver metastases. But using Opdivo in the first line did not result in longer time before cancer progression and did not increase survival when compared to chemotherapy in this trial, known as Checkmate-026. Additional studies are ongoing, including studies of Opdivo given with Yervoy (ipilumimab), a combination approved in melanoma, for first-line treatment of lung cancer.
There was also a third lung cancer immunotherapy drug making news. Data on the new drug Tecentriq (atezolizumab) was presented at the same session. Tecentriq is slightly different as it targets the PD-L1 protein itself, not its partner PD-1 like Keytruda and Opdivo. In the large, Phase III OAK study, patients taking Tecentriq lived 4.2 months longer (13.8 months total) than those on chemotherapy. All patients had received prior chemotherapy and their cancers did not have to be high for the biomarker to enroll on the study. (Although those with high (>50%) PD-L1 levels tended to survive longer – a median 20.5 months).
Take home point: We expect that Tecentriq will also be approved soon by the FDA for the treatment of lung cancer in patients who have already received chemotherapy. Tecentriq was approved to treat lung cancer on Tuesday, October 18, 2016.
There is an additional important point to note across all of these studies that underscores the importance of biomarker testing. In the trials for all three drugs, patients who had an EGFR mutation showed less benefit from the immunotherapies. This indicates that patients with EGRF, ALK or ROS mutations should likely be given a targeted therapy and not an immunotherapy first-line. We encourage patients with non-small cell lung cancer to have biomarker testing and to discuss all options with their treatment team.
All in all, while there is still a lot of research to be done, this is an exciting time for lung cancer research as new therapies and new combinations continue to show promise for lung cancer patients.
For questions about your treatment options or lung cancer in general, please call our HelpLine at 1-800-298-2436 or email firstname.lastname@example.org.