Podcast 300: NADIM II trial offers “quite exciting” results in lung cancer

A VIDEO RECORDING OF THIS INTERVIEW IS AVAILABLE HERE.

We’re back with another interview from this year’s IASLC conference.

This time, Christine Sadlowski and Dr. Julia Rotow interview Dr. Mariano Provencio about the survival outcomes from the NADIM II trial. In that trial, patients with resectable stage III AB non-small cell lung cancer received nivolumab plus chemotherapy versus chemotherapy alone.

Overall survival at 5 years in these patients has been roughly 30%, according to Provencio. With the addition of chemo-immunotherapy, patients who showed a complete pathological response were all alive at the 3-year mark. These results, according to Rotow, are “really quite exciting.”

INTERVIEW TRANSCRIPT

Christine Sadlowski:

This is part of the NEJM Group coverage of the IASLC’s 2022 World Conference on Lung Cancer. I’m Christine Sadlowski, and with me Dr. Julia Rotow, a clinical oncologist at Dana-Farber Cancer Institute in Boston. We’re here to interview Dr. Mariano Provencio, Chair of Medical Oncology at the Hospital Universitario Puerta de Hierro Majadahonda in Madrid in Spain. He is the lead author on NADIM II, a phase 2 trial of neoadjuvant nivolumab added to chemotherapy for resectable stage III AB non-small cell lung cancer. Welcome.

Dr. Mariano Provencio:

Thank you.

Christine Sadlowski:

So first, I’d like to ask you about the history of this research because these findings come after several previous studies, including NADIM nivolumab in this clinical setting. Can you refresh us briefly on what is known so far?

Dr. Mariano Provencio:

We studied the combination with nivolumab plus chemotherapy in NADIM I. It was a clinical trial focused on stage IIIA according to the 7th edition. It was a phase two trial. We obtained very exciting results: in overall survival, three times the historical series; in DFS [disease-free survival] around 77 percent at two years — almost double the historical series — and also early results in PCR, pathological complete response, almost 60 percent.

Then following that was the second clinical trial comparing nivolumab plus chemotherapy versus chemotherapy, and this is NADIM II.

Dr. Julia Rotow:

Thank you, Dr. Provencio. So, when you think about what we knew already in the field, could you take us through some of the key findings from the NADIM II study and what these might add to our current understanding of nivolumab in this setting?

Dr. Mariano Provencio:

In NADIM II, the primary objective was complete pathological response, and we obtained higher complete pathological response in the experimental arm. Nivo plus chemo versus chemo: Odds Ratio 7.88; p = 0.0068. We presented at the last lung cancer congress (IASLC) more progress, in PFS longer with hazard ratio of 0.48 and more overall survival hazard ratio of 0.40. And this is quite amazing results, in my opinion, comparing with chemotherapy arm.

Christine Sadlowski:

Can I go back a little bit and say in this particular presentation you’re showing primarily secondary outcomes, is that correct?

Dr. Mariano Provencio:

We presented the primary end point was a complete pathological response. It was positive and then we presented in this congress the secondary outcomes, survival outcomes, yes.

Christine Sadlowski:

And they were at 12 and 24 months, correct?

Dr. Mariano Provencio:

Correct.

Christine Sadlowski:

I was struck by the finding on