Targeted Treatment Pathways in Lung Cancer: Navigating Beyond Initial Diagnosis

In 2021, it is estimated that more than 235,000 Americans may be diagnosed with lung cancer. The five-year survival for early forms of the disease is approximately 60 percent. However, about 56 percent of patients have metastatic disease at the time of diagnosis, meaning the cancer has already spread beyond the lungs. For those with metastatic disease (stage IV), the five-year relative survival rate is just over 6 percent.

Debbie,* a psychotherapist with three adult children and two grandchildren, was leading an active life working, traveling and enjoying playing tennis, when she told her doctor about persistent pain in her upper back. Following imaging tests, she was diagnosed with an early stage of lung cancer which was initially successfully treated with surgery. But months later, Debbie felt something still wasn’t right.

“I was in Florida playing tennis and did not have the endurance I thought I should have, but I attributed it to the humidity. When I returned from my trip, I had another scan done and I was shocked to be told I had Stage IV metastatic non-small cell lung cancer,” Debbie recalls. “I felt overwhelmed at first. But I quickly took action and connected with the lung cancer community through patient organizations, which provided me with important tools to navigate my diagnosis.”

Debbie learned that the initial diagnosis only told part of the story. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Within NSCLC, researchers have identified several different genetic alterations in NSCLC cancer cells that drive the cancer’s growth, such as mesenchymal-epithelial transition (MET) exon 14 skipping alterations, a type of alteration that is estimated to occur in 3 to 4 percent of patients with NSCLC. These tumor alterations can be identified through biological markers, or biomarkers—and may be used to identify appropriate treatment options.

Diagnostic Tools

More than half of patients with NSCLC may have genetic alterations driving their tumor growth. Using comprehensive biomarker testing is important to identify these genetic mutations or other markers which may help doctors make decisions about appropriate treatment plans. Biomarker testing may also be called genomic testing, genomic profiling or molecular testing. Test results can be used to identify appropriate treatment options. Recent advancements in targeted treatments have increased the options available to patients with metastatic NSCLC.

“One of the most important things I learned from others with lung cancer is how valuable biomarker testing can be in securing a complete diagnosis,” Debbie said. “When I got a second opinion around my diagnosis, my oncologist told me I had the MET gene mutation. I was disappointed that I didn’t have this critical information at my initial diagnosis.*”

Debbie says her experience shows the value of seeking out community resources and advocating for oneself to ensure a comprehensive diagnosis, including biomarker testing. With a full picture of their disease, people with lung cancer can work with their care providers to develop an appropriate care plan for that patient.

For adults with metastatic NSCLC with METex14 skipping alterations, the US Food and Drug Administration has approved a targeted treatment option, called TEPMETKO® (tepotinib). 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

EMD Serono Inc., is the Healthcare business of Merck KGaA, Darmstadt, Germany in the US and Canada.

* Debbie has not received treatment with TEPMETKO. The views and opinions expressed are individual to this particular patient and may not reflect the experiences of other patients as individual results may vary. Patients should always talk to their doctors with any questions. Debbie has had a paid relationship with EMD Serono.

Please see the full Prescribing Information and Medication Guide for additional Important Safety Information for TEPMETKO.

For more information on metastatic NSCLC with METex14 skipping alterations, visit: www.TEPMETKO.com.

TEPMETKO® Indication and Important Safety Information

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.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

TEPMETKO can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Immediately withhold TEPMETKO in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified. ILD/pneumonitis occurred in 2.2% of patients treated with TEPMETKO, with one patient experiencing a Grade 3 or higher event; this event resulted in death.

TEPMETKO can cause hepatotoxicity, which can be fatal. Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TEPMETKO, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop increased transaminases or total bilirubin. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue TEPMETKO. Increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST) occurred in 13% of patients treated with TEPMETKO. Grade 3 or 4 increased ALT/AST occurred in 4.2% of patients. A fatal adverse reaction of hepatic failure occurred in one patient (0.2%). The median time-to-onset of Grade 3 or higher increased ALT/AST was 30 days (range 1 to 178).

TEPMETKO can cause embryo-fetal toxicity. Based on findings in animal studies and its mechanism of action, TEPMETKO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment with TEPMETKO and for one week after the final dose.

Avoid concomitant use of TEPMETKO with dual strong CYP3A inhibitors and P-gp inhibitors and strong CYP3A inducers. Avoid concomitant use of TEPMETKO with certain P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

Fatal adverse reactions occurred in one patient (0.4%) due to pneumonitis, one patient (0.4%) due to hepatic failure, and one patient (0.4%) due to dyspnea from fluid overload.

Serious adverse reactions occurred in 45% of patients who received TEPMETKO. Serious adverse reactions in >2% of patients included pleural effusion (7%), pneumonia (5%), edema (3.9%), dyspnea (3.9%), general health deterioration (3.5%), pulmonary embolism (2%), and musculoskeletal pain (2%).

The most common adverse reactions (≥20%) in patients who received TEPMETKO were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea.

Clinically relevant adverse reactions in <10% of patients who received TEPMETKO included ILD/pneumonitis, rash, fever, dizziness, pruritus, and headache.

Selected laboratory abnormalities (≥20%) from baseline in patients receiving TEPMETKO in descending order were: decreased albumin (76%), increased creatinine (55%), increased alkaline phosphatase (ALP) (50%), decreased lymphocytes (48%), increased alanine aminotransferase (ALT) (44%), increased aspartate aminotransferase (AST) (35%), decreased sodium (31%), decreased hemoglobin (27%), increased potassium (25%), increased gamma-glutamyltransferase (GGT) (24%), increased amylase (23%), and decreased leukocytes (23%).

The most common Grade 3 to 4 laboratory abnormalities (≥2%) in descending order were: decreased lymphocytes (11%), decreased albumin (9%), decreased sodium (8%), increased GGT (5%), increased amylase (4.6%), increased ALT (4.1%), increased AST (2.5%), and decreased hemoglobin (2%).

A clinically relevant laboratory abnormality in <20% of patients who received TEPMETKO was increased lipase in 18% of patients, including 3.7% Grades 3 to 4.

Additional information for people with NSCLC:

For more information about TEPMETKO, please see full Prescribing Information, and visit www.TEPMETKO.com.

US-TEP-00344 June 2021

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