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AstraZeneca VP, Head of US Lung Cancer Franchise Discusses the Recent FDA Approval of TAGRISSO


In an interview with Pharm Exec Associate Editor Don Tracy, Arun Krishna, VP, Head of US Lung Cancer Franchise, AstraZeneca, talks about the FDA's approval of TAGRISSO with the addition of chemotherapy in adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

PE: Recently, AstraZeneca announced the FDA approval for TAGRISSO with the addition of chemotherapy in adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). For our audience, can you briefly explain what this could mean for the future of lung cancer treatment?

Krishna: FLAURA2 is the study. It’s a follow up of FLAURA, where it was actually a TAGRISSO monotherapy, which is provided in the first-line metastatic EGFR patients. Now, FLAURA2 is really TAGRISSO, which is in addition to chemotherapy. The rationale for doing that study was that we believe there is a subset of the population which requires more intensification of treatment. The study results basically showed that not just across the whole population, but also in the subsets of patients who have CNS metastases or a hard-to-treat mutation which is L858R. The addition of chemotherapy dramatically improves progression-free survival. It’s another option for clinicians to use for patients in the first-line treatment, and specifically for patients who require a bit more intensification by the addition of chemo.

PE: The FDA based their approval on data from your FLAURA2 Phase III trial. Can you touch upon what the data entailed?

Krishna: As you can see with the data, we have shown a significant in terms of our primary endpoint, which is PFS. We’ve seen a risk reduction of more than 40% in those patients. If you talk about some of the hard-to-treat population, which is L858R and CNS, we've seen a significant increase in terms of the progression-free survival benefit of more than nine months across all of these patient groups, which again means that these patients are progression-free for a longer period of time with the addition of chemotherapy.

PE: Do you believe that there is potential for it or another medication to eventually prevent the need for chemotherapy altogether?

Krishna: I don't think there's necessarily a need to eliminate chemotherapy at all. For example, when I talk about TAGRISSO as a monotherapy, which is the current standard of care, that has no chemo in it, and we believe that majority of the patients are going to benefit from it, which is around 60-70%. As I said earlier, we might add chemotherapy for the remaining 20-30% because they need the additional intensification.

PE: What is in the future for TAGRISSO in terms of research and development for other potential indications?

Krishna: When you talk about EGFR mutation, the name that comes to mind is TAGRISSO because we really want it to be the backbone treatment for EGFR patients. EGFR is an oncogene, and we need to target the driver of that mutation. In general, TKIs are being shown working in that space. For TAGRISSO, we really want to look across the spectrum, both early as well as in late stage. On Monday, we received exciting news that the LAURA trial was the use of TAGRISSO in stage three. These are earlier stages, with patients following CRT, which is concurrent chemo radiation. The press release highlights it. We're also looking at other combinations of TAGRISSO and ADCs in the late-stage area, both in first line as well as second line.

PE: Are there any other developments from AstraZeneca’s oncology pipeline that you’d like to highlight?

Krishna: Overall, it's a really exciting time for AstraZeneca in the oncology space. In five years, we have grown in terms of revenue. I think there are a lot of things to look forward to. One example would be the ADCs. We have Dato-DXd, which is an ADC which, again, as part of the press release on Monday, has been accepted by FDA for filing. We are very excited about that because we believe that the ADCs will actually replace chemotherapy in the future. We are looking forward to seeing some of those results in the upcoming Congress.

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