Osimertinib: A Bright Spot at the End of a Dismal 2020

Mark G. Kris, MD


January 19, 2021

This transcript has been edited for clarity.

This is Mark Kris from Memorial Sloan Kettering, sharing some exceptionally good news at the end of an exceptionally difficult year, which is the approval of osimertinib by the US Food and Drug Administration (FDA).

Osimertinib is an adjuvant treatment for patients with stage IB to IIIA lung adenocarcinomas that harbor an epidermal growth factor receptor (EGFR) mutation.

The superb results of the randomized phase 3 ADAURA trial led to its approval. This trial showed a meaningful improvement in disease-free survival in the overall patient population and in specific stages of lung cancers. Patients with stage IB lung cancer had a 14% improvement in disease-free survival compared with placebo; for those with stage II, a 35% improvement; and for those with stage IIIA, a 56% improvement — substantial improvements in disease-free survival compared with placebo. All of the primary and secondary endpoints were met. The drug was well tolerated.

This approval finally gives us an adjuvant therapy that we can recommend to the majority of patients, unlike our current standard of cisplatin-based chemotherapy.

Remember that in this trial, patients who were candidates for stage-specific therapy were encouraged to receive it, and many patients did receive cisplatin-based chemotherapy. Until more data come out, patients who are fit to receive stage-appropriate therapy should get it.

This trial is extremely important for a number of reasons. It marks the emergence of targeted therapy in the adjuvant setting for patients with lung cancer. This is a landmark for that. I believe we will see many other targeted therapies move into this space as well. A foothold in this new territory has been achieved, and others will follow suit.

This is also a landmark in that it's the first approval for patients with any type of stage IB lung cancer. In the ASCO guidelines for stage IB lung cancer, consultation with a medical oncologist was recommended, but chemotherapy was not recommended for routine use. For these patients with stage IB disease, we now have a standard therapy to recommend if the tumors harbor EGFR mutations.

Another important issue is the foothold we now have for doing next-generation sequencing (NGS). We need to know if patients have EGFR mutations. The best way to do that is to use NGS testing. Through this, we will find other targets as well. The use of that information is evolving, but I think the information should be out there. Clinicians and patients should use it as best they can to choose additional therapies. To me, testing is now a standard of care in patients with surgically resected disease, and NGS testing makes the most sense.

Also of importance is that the endpoint of this trial was disease-free survival. Disease-free survival is the most important thing I can offer a patient. They want their lives back. They want a life that's free of cancer and the challenges of having cancer. Putting patients on that disease-free survival curve and keeping them there is important to their well-being. To me, it's also a step toward cure.

On a personal note, for more than a decade, we have fought for these adjuvant trials to be conducted. The data supported them; but for one reason or another, they just weren't done. We now have a trial that's completed, it's FDA approved, it's in the guidelines, and it's going to change the face of therapy.

This is very good news — targeted therapy that is useful in all stages, from IB and up. This is a great opportunity for our patients today, and I believe it's a harbinger of the utility of other targeted therapies moving forward.

Mark G. Kris, MD, is chief of the thoracic oncology service and the William and Joy Ruane Chair in Thoracic Oncology at Memorial Sloan Kettering Cancer Center in New York City. His research interests include targeted therapies for lung cancer, multimodality therapy, the development of new anticancer drugs, and symptom management with a focus on preventing emesis.

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