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Dr. Gray:
Hello, this is CME on ReachMD, and I'm Dr. Jhanelle Gray. Today, I will provide an update on real-world long-term data on consolidation immunotherapy after concurrent chemoradiation. We know the PACIFIC study, the 3-year and the 5-year updates, that their value have improved progression-free survival [PFS] and overall survival.

When we look at the real-world data, this accumulated to over 1,300 patients at 11 participating sites, mainly in Europe. Data was extracted from the medical records of patients. The primary endpoint here at median progression-free survival was 21.7 months versus what we saw in the PACIFIC at 16.9 months. We can see here, also, that the progression-free survival that was observed at a PD-L1 status of greater than or equal to 1% trended for an improved outcome, versus those that had a PD-L1 status of less than 1%. Adverse events are important to look at in this population. Permanent discontinuation occurred in about 9.5% of patients due to pneumonitis or interstitial lung disease [ILD]. The pneumonitis and interstitial lung disease was mainly moderate in nature and majority of patients required corticosteroids. The median time of onset of this pneumonitis and ILD was 2.5 months. Overall, the PACIFIC real-world study supports use of durvalumab for standard of care treatment for patients with unresectable non-small cell lung cancer.

Now, shifting gears a little bit, we saw the press release for the PACIFIC-2 study, which was actually negative. The study did not meet its primary endpoint with a hazard ratio of 0.85, and the overall survival also had a hazard ratio, unfortunately, of 1.03. This has raised some questions about why is this study negative? There is some thought that this has to do with the patient population. This includes a patient population that was 29% to 35% mainly Asian. We also have the PD-L1 status, where 51% to 55% of patients had a PD-L1 status greater than or equal to 1%, and EGFR mutation status was unknown in about 39% to 45% of patients.

We also have to look at toxicity. While pneumonitis was balanced across both arms, more adverse events leading to discontinuation occurred in durvalumab group, and this, we think, may have contributed to some of the findings that we've seen with the PACIFIC-2 study.

We also have the PACIFIC-5 study, which is ongoing, which looked at sequential chemoradiation or concurrent chemoradiation and randomized patients to durvalumab versus placebo. We are also excited to see the results of the ECOG [Eastern Cooperative Oncology Group] study, which moves up the durvalumab with concurrent chemoradiation, and this differs from the PACIFIC-2 study because in the control arm, patients also received consolidation durvalumab. This is almost similar to PACIFIC-2 versus the PACIFIC study. We know from the LAURA study press release, also, which looked at EGFR mutant non-small cell lung cancer, demonstrated overwhelming efficacy.

In summary, it's important that we get molecular testing completed in patients with stage III unresectable non-small cell lung cancer, and consolidation durvalumab remains our current standard, and we eagerly look forward to the manuscript for the PACIFIC-2 study, as well as the findings from the ECOG study.

I hope you found this update useful and thank you for listening.

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