INDICATION
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

SUMMARY OF WARNINGS AND PRECAUTIONS
TEPMETKO is associated with the following Warnings and Precautions: interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, pancreatic toxicity, and embryo-fetal toxicity.

Please see additional Important Safety Information at the end of this video and the accompanying full Prescribing Information for TEPMETKO.

Dr Alex Spira
Hi. I'm Dr Alex Spira. I'm a medical oncologist with Virginia Cancer Specialists in Fairfax, Virginia. I have several years experience with MET exon 14 skipping non-small cell lung cancer.

For my eligible patients who are diagnosed with MET exon 14 positive metastatic non-small cell lung cancer, I start them on TEPMETKO.

TEPMETKO was studied in the VISION Trial, the largest and longest clinical trial of its kind, in MET exon 14 positive metastatic non-small cell lung cancer. The clinical evidence for TEPMETKO supports a robust and lasting response. I want to give each of my eligible patients diagnosed with MET exon 14 positive metastatic non-small cell lung cancer the opportunity to receive the appropriate therapy.

I also choose TEPMETKO as my first choice for appropriate patients under my care who were previously treated for MET exon 14 positive metastatic non-small cell lung cancer.

The VISION Trial data is meaningful to me in my practice, because the trial represents real-world patients. There were many patients from many trial sites from around the world, including community-based practices, so reflecting real-world patients. And it demonstrated very good outcomes for patients taking a targeted therapy in the confines of their home, not having to come in for infusions.

As I mentioned, the pivotal clinical trial for TEPMETKO, the VISION Trial, is the largest and longest in MET exon 14 positive metastatic non-small cell lung cancer. It included 313 patients and had a long-term follow-up of up to 6 years, ranging from 0.3 to 71.9 months. The study included both treatment-naïve and previously treated patients with MET exon 14 positive metastatic non-small cell lung cancer.

All patients received TEPMETKO, 450 milligrams, once daily, until disease progression or unacceptable toxicity. The primary analysis had a median follow-up of more than 11.8 months. And the long-term follow-up had a median of 32.6 months.

The study assessed confirmed overall response rate as the major efficacy outcome, as well as duration of response, and disease control response efficacy outcomes.

First, let's take a look at the robust and lasting responses in the 164 treatment-naïve patients who received TEPMETKO as first-line treatment.

As you can see, these long-term follow-up data show that the overall response rate achieved with TEPMETKO was 57%.

Looking at the duration of response at long-term follow-up, the range was 1.3 months to 56.6 months. Sixty-six percent of patients responded for 6 months or longer. And 40% responded for a year or longer.

Continuing with the additional data from the trial, for the total treatment-naïve patient population, the duration of treatment showed that 69 patients, or 42.07%, had at least 1 dose reduction. And 100 patients, or 61%, had at least 1 dose interruption or delay.

When patients come in with newly diagnosed metastatic non-small cell lung cancer, which has MET exon 14 skipping alterations, we're typically faced with the options of either chemo-immunotherapy or targeted treatment, such as TEPMETKO. I opt for TEPMETKO because I believe it is a better-tolerated treatment. Our patients are not necessarily fans of chemotherapy. And we're trying to avoid toxicity. Patients can be treated with once-daily dosing at home and not have to worry about coming to the office for infusions.

Turning now to the previously treated patient population, we see robust and lasting responses at follow-up with TEPMETKO. The overall response rate was 45%.

And the duration of response was from 1.4 to 67.6 months. Sixty-six percent of patients responded for 6 months or longer. And 36% of patients responded for 1 year or longer.

And for the duration of treatment among the total previously treated patient population, there were 47 patients, or 31.5%, who had at least 1 dose reduction, and 84 patients, or 56%, who had at least 1 dose interruption or delay.

In my practical experience, the efficacy endpoints in this VISION study were very reflective of real-world patient information. When you look at the response rates, there was a significant response rate. You're also looking at duration of response. And that is a very meaningful clinical impact, in my opinion and my experience, because it tells us, not only does the drug work, but it can work for a while.

The safety and tolerability of TEPMETKO were established in 313 patients. Most adverse reactions observed in the VISION Trial were Grade 1 or 2. The adverse reactions that occurred in 10% or more of patients, for all grades, and for Grades 3 to 4, are shown in the bar chart.

Peripheral edema, a class effect of MET inhibitors, was the most common treatment-related adverse event observed during the trial.

Eight percent of patients had to permanently discontinue TEPMETKO due to edema.

The most common adverse events, in my experience with the use of TEPMETKO, is in fact edema. It happens not uncommonly, but can be managed. I typically start patients with telling them to elevate their legs, such as when they're sitting at home. I actually tell them to walk around, because I believe that mobilized fluids, so more walking, is always better. But when they're at home relaxing, keep their feet elevated.

I sometimes use compression stockings. And I also tell them to try and limit their salt intake as much as they possibly can, realizing that that sometimes is tough to do in our patients with cancer. If that doesn't work, I will put in a dose adjustment or dose hold, as needed, to allow some of these effects to resolve.

Of patients who receive TEPMETKO and experience an adverse reaction, 25% had permanent discontinuation, 53% had dosage interruptions, and 36% had dose reductions.

Fatal adverse reactions occurred in 1.9% of patients, and serious adverse reactions occurred in 51% of patients.

The percentage of patients with selected laboratory abnormalities, as well as the most common Grade 3 to 4 laboratory abnormalities that were reported in the trial are shown here.

My first preference is to start TEPMETKO in all my eligible patients diagnosed with MET exon 14 positive metastatic non-small cell lung cancer. Based upon the robust findings established with the VISION Trial, along with my own real-world experience, I believe that, by initiating TEPMETKO, and providing clinical management, I am giving my patients a way to potentially extend their survival.

Thank you for watching.