Table of contents
- Trial overview
- Study in metastatic pancreatic cancer
- Studies in non-small cell lung cancer
- Phases and study design
- Main endpoints being measured
- Who the trials are for
- Key points from the trial data
Trial overview
The source data describe three interventional studies of 2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE, also listed in the trial titles as BMS-986504 and Navlimetostat.[1][2][3] All three studies are marked Authorised and focus on cancers with homozygous MTAP deletion, which means both copies of the MTAP gene are missing.[1][2][3]
Two studies are in metastatic non-small cell lung cancer, and one study is in untreated metastatic pancreatic ductal adenocarcinoma.[1][2][3] The studies compare the research treatment with placebo in some settings, and with standard cancer treatment combinations in others.[1][3]
Study in metastatic pancreatic cancer
One trial is titled as a study of BMS-986504 in combination with nab-p/gem versus placebo in combination with nab-p/gem in untreated metastatic PDAC with homozygous MTAP deletion.[1] PDAC means pancreatic ductal adenocarcinoma, which is a common type of pancreatic cancer.[1]
This study is designed to see whether the combination can prolong the time to disease worsening on scans and prolong survival.[1] The primary outcome is listed as time to disease worsening on scans and time to death, which are patient-important measures of whether the disease stays controlled longer.[1]
The trial is in Phase 4 in the source record and has an enrollment of 470 participants.[1] The study includes people with untreated metastatic disease, meaning the cancer has spread and has not yet been treated in this study setting.[1]
Studies in non-small cell lung cancer
One lung cancer study is titled as a study of Navlimetostat (BMS986504) in participants with pre-treated advanced or metastatic non-small cell lung cancer with homozygous MTAP deletion.[2] This means the study includes people whose lung cancer is already advanced and who have had prior treatment.[2]
This study evaluates objective response, which means how many participants have their tumors shrink or disappear based on scan rules called RECIST v1.1.[2] The study is listed as Phase 2 and has an enrollment of 130 participants.[2]
The other lung cancer study is a first-line metastatic non-small cell lung cancer trial that tests BMS-986504 with pembrolizumab and chemotherapy versus placebo with pembrolizumab and chemotherapy in people with homozygous MTAP deletion.[3] “First-line” means the first treatment given for that metastatic cancer setting.[3]
This study has two main goals in Phase 3: compare progression-free survival and compare overall survival between the treatment groups.[3] The source record lists an enrollment of 580 participants and marks the study as Phase 4.[3]
Phases and study design
The trial data show a mix of phase labels and phase objectives.[1][2][3] One study is a Phase 2 trial focused on tumor response, while the other two are labeled Phase 4 in the source records but include Phase 3 outcome goals such as progression-free survival and overall survival.[1][2][3]
All three studies are interventional, which means the researchers are assigning a treatment plan and then measuring the results.[1][2][3] The treatment plans include the study drug alone or with other cancer medicines, and some groups receive a matching placebo instead of the study drug.[1][3]
Main endpoints being measured
The main outcome in the pancreatic cancer study is time to disease worsening on scans and time to death.[1] These outcomes help show whether treatment delays cancer growth and may help people live longer.[1]
The Phase 2 lung cancer study measures objective response using RECIST v1.1.[2] This is a standard way to judge whether tumors have shrunk in a reliable and fair way.[2]
The first-line lung cancer study measures progression-free survival in both Phase 2 and Phase 3 parts, and overall survival in Phase 3.[3] Progression-free survival means the time before the cancer gets worse, and overall survival means the time people stay alive after starting study treatment.[3]
Who the trials are for
These studies are aimed at people with homozygous MTAP deletion and advanced cancer.[1][2][3] The pancreatic study is for people with untreated metastatic pancreatic ductal adenocarcinoma, while the lung cancer studies are for people with advanced or metastatic non-small cell lung cancer, including people who are pre-treated or starting first-line therapy.[1][2][3]
The source data do not provide full inclusion or exclusion rules, so the most important known eligibility feature is the cancer type plus the MTAP deletion status.[1][2][3]
Key points from the trial data
Three authorised studies are listed for 2-[4-[4-(AMINOMETHYL)-1-OXO-2H-PHTHALAZIN-6-YL]-2-METHYLPYRAZOL-3-YL]-4-CHLORO-6-CYCLOPROPYLOXY-3-FLUOROBENZONITRILE.[1][2][3]
One study is in untreated metastatic pancreatic ductal adenocarcinoma, and two are in metastatic non-small cell lung cancer.[1][2][3]
The studies measure response, progression-free survival, time to disease worsening, and overall survival.[1][2][3]
Enrollment ranges from 130 to 580 participants across the trials.[1][2][3]
The trial designs include placebo-controlled comparisons and combination treatment plans.[1][3]
