ELCC 2021 | PACIFIC 6: durvalumab after sCRT in patients with NSCLC
Marina Garassino, MD, University of Chicago, Chicago, IL, shares an update on the Phase II PACIFIC 6 trial (NCT03693300) investigating the safety of durvalumab after sequential chemoradiotherapy (sCRT) in patients with stage III, unresectable non-small cell lung cancer (NSCLC). Initial analysis of data from 50 patients receiving durvalumab for a median of 24 weeks indicates that durvalumab after sCRT has a similar safety profile to that of durvalumab after concurrent chemoradiotherapy. This video was recorded at the virtual European Lung Cancer Congress (ELCC) 2021.
Transcript (edited for clarity)
PACIFIC-6 is a study, non-randomized, single-arm, Phase II, multi-center trial with two cohorts. One cohort is for patients with performance status zero or one, and the second cohort is for patients with performance status two.
The eligible patients for the PACIFIC-6 have a stage three unresectable non-small cell lung cancer, but they are not eligible from the beginning for a concurrent chemoradiation...
PACIFIC-6 is a study, non-randomized, single-arm, Phase II, multi-center trial with two cohorts. One cohort is for patients with performance status zero or one, and the second cohort is for patients with performance status two.
The eligible patients for the PACIFIC-6 have a stage three unresectable non-small cell lung cancer, but they are not eligible from the beginning for a concurrent chemoradiation. So, if you remember in the PACIFIC, in the big PACIFIC, the patients had to receive a concurrent chemoradiation and then were randomized to receive either durvalumab for one year or placebo after 42 days after their completion of concurrent chemoradiation.
However, as we know from our daily practice, there are several problems about the volume of the tumor, the access to the radiation oncology, there are patient conditions. And so not all the patients are eligible from the beginning for concurrent chemoradiation. And it is also quite frequent to have patients that they need the sequential chemoradiation.
So, the aim of the PACIFIC-6 is exactly to identify the safety profile of durvalumab for two years after a sequential chemoradiation. So, the results that I presented in ACC suggested that the safety profile is very similar to what it was observed in the PACIFIC after the concurrent chemoradiation, and they are mainly represented by the pneumonitis. There was only one fatal adverse event and all the other patients went well. So, the majority of the patients who stop at the durvalumab, and this was a pre-specified analysis in 50 patients so we will report elsewhere the overall cohort, these patients had mainly pneumonitis and 50% of them arrived at six years, six months.
The majority of patients who stopped before the treatment, they were mainly for progressive disease. So potentially, this is clearly a preliminary safety analysis, so, the trial now finished the enrolment and so the data will be presented very soon. And however, also in this preliminary analysis, we can say that the safety profile is quite similar to what it was already observed in the PACIFIC.
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Disclosures
Marina Garassino has received personal fees or grants from AstraZeneca, MSD, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Inivata, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati Therapeutics, Daiichi Sankyo, Bayer, GlaxoSmithKline S.p.A, Sanofi-Aventis,, Blueprint Medicine, Janssen and Regeneron Pharmaceuticals; and has received institutional fees or grants from Eli Lilly, Pfizer, AstraZeneca, MSD, BMS, Celgene, Incyte, MedImmune, Novartis, Pfizer, Roche, Tiziana Sciences, GlaxoSmithKline S.p.A, Spectrum Pharmaceuticals, Clovis, Merck Serono, Bayer, Sanofi-Aventis, Blueprint Medicine, Merck KGaA, Ipsen, Exelisis, Otsuka Pharma, Janssen and Spectrum Pharmaceuticals.
