nazartinib (EGF816) / Novartis - LARVOL DELTA

Capmatinib plus nazartinib in patients with EGFR-mutated non-small cell lung cancer. (PubMed, Eur J Cancer) - P1/2 | "Capmatinib plus nazartinib showed antitumor activity in patients with EGFR-TKI-resistant, EGFR-mutated NSCLC. The overall safety profile was acceptable."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A first-in-human study of oral TNO155 (batoprotafib) alone and in combination with EGF816 (nazartinib) in adult patients with advanced solid tumors (AACR 2025) - P1 | "Arm B EXP required progression on osimertinib as the most recent prior therapy. As of 1-Aug-2024, 227 pts were treated (Arm A: ESC; n=141; EXP; n=42; Arm B; ESC; n=29; EXP; n=15), and 224 (98.6%) pts had discontinued study treatment, mainly due to progressive disease. TNO155 shows acceptable safety as a SA and with nazartinib and demonstrates evidence of MAPK pathway suppression in tumors."

Clinical • Combination therapy • First-in-human • Metastases • P1 data • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • DUSP6 • KRAS • NRAS

Real-world outcomes (RWO) of oral MET-inhibition in EGFR MET-amplified (MET-amp) NSCLC (ELCC 2026) - "Treatment regimens included tepotinib (tepo) with osimertinib (Osi) (n=14), capmatinib (Cap) with nazartinib (n=3), savolitinib with Osi (n=1), vebreltinib with Osi (n=1), Cap with Erlotinib/Gefitinib (n=3). MET-treated patients with MET:CEP7 ratio ≥2 (n=10) had similar responses to those with ratio <2 (n=5) (mOS 45.4 vs 49.8m, mPFS on MET-i 8.2 v 6.8m, DOR 8.9 v 6.2m).Conclusions Combination EGFR and MET inhibition benefited both denovo Met-amp and post TKI MET resistant EGFR patients. Oral combinations remain an important option for patients."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | Phase classification: P4 ➔ P2 | Trial completion date: May 2019 ➔ Jul 2022 | Trial primary completion date: Jan 2019 ➔ Dec 2020

Enrollment closed • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | N=60 ➔ 40

Enrollment change • Monotherapy • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Dec 2020 ➔ Jul 2027

Monotherapy • Trial primary completion date • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

Monotherapy • New P4 trial • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Apr 2019 ➔ Apr 2022

Monotherapy • Trial primary completion date • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=40 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Apr 2022 ➔ May 2019

Monotherapy • Trial primary completion date • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Jul 2019 ➔ Jan 2019

Monotherapy • Trial primary completion date • Oncology • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Solid Tumor

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Recruiting | Trial completion date: Jul 2022 ➔ Jul 2027

Enrollment open • Monotherapy • Trial completion date • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2021 ➔ May 2022 | Trial primary completion date: May 2021 ➔ May 2022

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Oct 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=157 ➔ 105

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Nov 2022 ➔ Sep 2023 | Trial primary completion date: Nov 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2024 ➔ Nov 2022 | Trial primary completion date: Mar 2024 ➔ Nov 2022

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2022 ➔ Mar 2024 | Trial primary completion date: May 2022 ➔ Mar 2024

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=157 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Apr 2025 ➔ Oct 2025 | Trial primary completion date: Apr 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor