Updated Results from NT-001 Trial of NEO-PV-01 Demonstrate Prolonged Progression-Free and Overall Survival vs. Historical Benchmark Data
Advanced Process Development Supports Clinical Trial Application to be Filed in Europe by End of Year for T cell Therapy Candidate NEO-PTC-01
CAMBRIDGE, MA, USA I November 08, 2019 I Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today presented updated data at the Society for Immunotherapy of Cancer’s (SITC) 34th Annual Meeting in National Harbor, MD.
“We are pleased to present these updates for both NEO-PV-01 and NEO-PTC-01, both of which demonstrate Neon’s continued leadership in advancing neoantigen-based science and drug development. We continue to believe that these personalized approaches to treating cancer represent significant potential to reshape the treatment landscape for solid tumors,” said Richard Gaynor, M.D., Neon’s President of Research and Development.
NEO-PV-01: Updated Results from the NT-001 Clinical Trial
Neon today announced updated results (August 2019 data cut) from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO® (nivolumab) in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer. Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) and overall survival (OS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data. Further, neoantigen-specific immune responses and epitope spread to RECON®-predicted targets were associated with longer PFS and major pathological responses post-administration of NEO-PV-01 in melanoma patients were also associated with longer PFS. The safety data for NT-001 were consistent with the safety profile for OPDIVO monotherapy. These updated results come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial. The NT-001 trial was initiated in November 2016 and completed enrollment in July 2018.
| NT-001 Clinical Trial Results August 2019 data cut; overall survival analysis includes previously censored patients from April 2019 data cut Initiated OPDIVO: Patients that received at least one dose of OPDIVO (ITT set) Initiated NEO-PV-01: Patients who received at least one dose of NEO-PV-01 (ITT subset)
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| Metastatic Melanoma |
Metastatic NSCLC |
Metastatic Bladder Cancer |
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| Initiated OPDIVO (ITT) |
Initiated NEO-PV-01 (ITT Subset) |
Initiated OPDIVO (ITT) |
Initiated NEO-PV-01 (ITT Subset) |
Initiated OPDIVO (ITT) |
Initiated NEO-PV-01 (ITT Subset) |
|
| NT-001 Enrollment (N) | 34 | 27 | 27 | 18 | 21 | 15 |
| NT-001 Median Follow-Up (months) | 20.3 | 20.3 | 15.2 | 15.2 | 17.5 | 17.5 |
| NT-001 Median PFS (months) | 15.1 | 23.5 | 4.3 | 8.5 | 5.6 | 5.8 |
| Historical Benchmark Median PFS (months) | 3.1-6.91 | – | 2.3-4.22 | – | 2.1-2.83 | – |
| NT-001 Median OS (months) | Not Reached | Not Reached | 16.2 | Not Reached | 20.7 | 20.7 |
| Historical Benchmark Median OS (months) | 15.7-37.61 | – | 12.2-14.42 | – | 9.7-15.93 | – |
| NT-001 1 Year Survival (%) | 85 | 96 | 59 | 83 | 60 | 67 |
| Historical Benchmark 1 Year Survival (%) | 59-741 | – | 51-562 | – | 44-573 | – |
| Objective Response Rate (ORR) (%) | 47 | 59 | 26 | 39 | 22 | 27 |
| Historical Benchmark ORR (%) | 27-441 | – | 19-262 | – | 21-243 | – |
1 Historical checkpoint inhibitor data for advanced or metastatic melanoma: Larkin, et al, JCO 2017; Schachter, et al, Lancet 2017; Wolchok, et al, NEJM 2017.
2 Historical checkpoint inhibitor data for advanced or metastatic non-small cell lung cancer: Borghaei, et al, Lancet 2015; Carbone, et al, NEJM 2017; Herbst, et al, Lancet 2016.
3 Historical checkpoint inhibitor data for advanced or metastatic bladder cancer: Balar, et al, Lancet 2017; Bellmunt, et al, NEJM 2017; Sharma, et al, Lancet 2016.
NEO-PTC-01: Advanced Process Development Supports Clinical Trial Application Filing in Europe by End of 2019
Neon continues to advance its preclinical and process development work for NEO-PTC-01, its personal neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor. NEO-PTC-01 leverages Neon’s RECON bioinformatics platform to individually select a set of neoantigen targets for each patient, and NEO-STIM™, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo. Neon believes that this approach will allow NEO-PTC-01, a non-engineered T cell product that leverages peripheral blood mononuclear cells (PBMCs) as its starting material, to specifically target each patient’s individual tumor with T cells that can drive a robust and persistent anti-tumor response.
In the update presented today at SITC, Neon demonstrated that it can reproducibly generate a potent T cell product from PBMCs of melanoma patients, as well as at therapeutic scale using a healthy donor sample. This process development work showed that NEO-PTC-01 induced multiple CD8+ and CD4+ T cell responses from both the memory and naïve T cell compartments. The induced T cell responses were mutant-specific, showed a polyfunctional profile and had a central and effector memory phenotype. The induced T cell responses had cytotoxic capability, shown by the recognition of antigen-expressing tumor cell lines. Importantly, NEO-PTC-01 induced T cell cultures that directly recognized autologous tumor digest.
Neon is focusing the initial clinical development of NEO-PTC-01 in patients with solid tumors that are refractory to checkpoint inhibitors. Neon expects to file a clinical trial application, or CTA, in Europe by the end of 2019 to evaluate NEO-PTC-01 in the solid tumor setting.
Details for the NEO-PV-01 poster presentation are as follows:
Presentation Title: Disease-related Biomarkers are Associated with Extended Progression-Free Survival after Treatment with NEO-PV-01 in Combination with Anti-PD1 in Patients with Metastatic Cancers
Poster Hall Hours: Friday, November 8 from 7:00 a.m. – 8:00 P.M. ET
Poster Number: P437
Location: Gaylord National Convention Center
Details for the NEO-PTC-01 poster presentation are as follows:
Presentation Title: The Development of an Autologous Neoantigen-Specific T cell Product from Peripheral Blood, NEO-PTC-01, through the ex-vivo Induction Protocol, NEO-STIM™
Poster Hall Hours: Friday, November 8 from 7:00 a.m. – 8:00 P.M. ET
Poster Number: P197
Location: Gaylord National Convention Center
The posters will also be made available at https://neontherapeutics.com/publications/.
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company.
About Neon Therapeutics
Neon Therapeutics is a clinical-stage immuno-oncology company and a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Neon is using its neoantigen platform to develop both vaccine and T cell therapies, including NEO-PV-01, a clinical-stage neoantigen vaccine for the treatment of metastatic melanoma, non-small cell lung cancer, and bladder cancer; NEO-PTC-01, a neoantigen T cell therapy for the treatment of solid tumors; and NEO-SV-01, a neoantigen vaccine for the treatment of a subset of hormone receptor-positive (HR+) breast cancer.
For more information, please visit neontherapeutics.com.
SOURCE: Neon Therapeutics
