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Based on early and positive efficacy data in Cohort A, the FDA granted TEPMETKO® (tepotinib) accelerated approval status1,2


Cohort A Efficacy1

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TREATMENT NAÏVE

(n=69)

mDOR BY BIRC

10.8months

(95% CI: 6.9, NE)

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PREVIOUSLY TREATED

(n=83)

mDOR BY BIRC

11.1months

(95% CI: 9.5, 18.5)

NCCN

PREFERRED


Tepotinib (TEPMETKO®) is recommended by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred systemic therapy option in the first-line/subsequent line setting for patients with metastatic METex14+ non-small cell lung cancer (category 2A)3‡§II

Cohort A + C# Efficacy4,5

ADDITIONAL EXPANDED ANALYSES**

Data cutoff as of February 2022

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TREATMENT NAÏVE
(n=164)
mDOR BY BIRC

46.4

months

(95% CI: 13.8, NE)

DCR

79%

(95% CI: 71.6, 84.7)

mOS

19.1

months

(95% CI: 13.7, 23.7)

mPFS

12.6

months

(95% CI: 9.6, 17.7)

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PREVIOUSLY TREATED

(n=149)

mDOR BY BIRC

12.4

months

(95% CI: 9.5, 18.5)

DCR

74%

(95% CI: 66.0, 80.7)

mOS

19.6

months

(95% CI: 15.2, 22.3)

mPFS

11.0

months

(95% CI: 8.2, 13.7)

Due to the single-arm design of the VISION Trial, no formal statistical comparisons were conducted, and data, including PFS and OS, were analyzed in a descriptive manner. For these reasons, results from this analysis should be interpreted with caution.

*ORR according to RECIST v1.1 as evaluated by a BIRC. If METex14 skipping mutation inhibitors have not previously been given. Category 2A definition: based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate. §See the NCCN Guidelines® for detailed recommendations, including other preferred options. IIThe NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques but do not endorse any specific commercially available biomarker assays or commercial laboratories.3  The analyses presented here includes all patients enrolled in Cohort A, including 2 patients who were identified as non-responders in the prescribing information, and patients enrolled in Cohort C with 3 months' follow-up. #In the pre-planned study design, Cohort C is a prespecified confirmatory cohort for Cohort A. Patients were not allowed to enroll in Cohort C until Cohort A was complete. **Updated data cutoff as of February 2022. Results are based on an interim analysis, which are subject to change on follow-up.

BIRC=Blinded Independent Review Committee; CI=confidence interval; DCR=disease control rate; mDOR=median duration of response; METex14+=mesenchymal-epithelial transition exon 14 skipping alterations; mOS=median overall survival; mPFS=median progression-free survival; NCCN=National Comprehensive Cancer Network; NE=not evaluable; NSCLC=non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.

IMPORTANT SAFETY INFORMATION AND INDICATION

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 ALT (44%), increased 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 3-4 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.

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.

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

References: 1. TEPMETKO® (tepotinib)  [prescribing information]. EMD Serono, Inc., Rockland, MA; 2021. 2. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. 2020;383(10):931-943. doi:10.1056/NEJMoa2004407 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023.  All rights reserved.  Accessed August 17, 2023.  To view the most recent and complete version of the guideline, go online to NCCN.org. 4. Thomas M, Garassino MC, Felip E, et al. Tepotinib in patients with MET exon 14 skipping NSCLC: primary analysis of the confirmatory VISION Cohort C. Presented at: International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer; August 6-9, 2022; Vienna, Austria. 5. Data on file. EMD Serono, Inc. Rockland, MA.