Table of Contents
- Overview of the trial program
- Breast cancer studies
- Lung cancer studies
- Gynecologic cancer studies
- Gastrointestinal cancer studies
- Urothelial and other cancer studies
- Main endpoints and what they mean
Overview of the trial program
The trial data show a broad research program for Sacituzumab Tirumotecan, also listed in several studies as MK-2870 or sac-TMT.[1] The studies are testing it alone or with other treatments such as pembrolizumab, bevacizumab, and chemotherapy in many cancer types.[1]
Most of the studies are Phase 3 trials, which means they compare the study treatment with standard care in larger groups of people.[1] There are also smaller Phase 1 and Phase 2 studies that focus on safety, tolerability, and early signs of benefit.[1]
Across the trial list, the main goal is to see whether Sacituzumab Tirumotecan can improve outcomes such as survival, cancer control, and response to treatment in selected patient groups.[1]
Breast cancer studies
Several trials study Sacituzumab Tirumotecan in breast cancer, showing that this is one of the main areas of research.[1] The target groups include locally recurrent unresectable or metastatic TNBC (triple negative breast cancer), hormone receptor positive breast cancer, and hormone receptor low positive/HER2 negative breast cancer.[1]
One Phase 3 study in locally recurrent unresectable or metastatic TNBC with PD-L1 CPS below 10 compares Sacituzumab Tirumotecan alone or with pembrolizumab against treatment of physician’s choice.[1] The main measures are progression-free survival and overall survival, which show how long cancer stays controlled and how long people live after treatment starts.[1]
Another large Phase 3 study in breast cancer looks at neoadjuvant treatment, which means treatment given before surgery.[1] It compares Sacituzumab Tirumotecan followed by carboplatin and paclitaxel, both with pembrolizumab, against chemotherapy-based treatment, and it measures pathological complete response and event-free survival.[1]
A separate Phase 3 study in people who have already had surgery for triple negative breast cancer compares MK-2870 plus pembrolizumab with pembrolizumab alone or pembrolizumab plus capecitabine.[1] Its main endpoint is invasive disease-free survival, which checks how long people remain free from invasive cancer after treatment.[1]
There is also a Phase 3 study in hormone receptor positive breast cancer that cannot be surgically removed.[1] It compares MK-2870 with or without pembrolizumab against treatment of physician’s choice and measures progression-free survival.[1]
Lung cancer studies
Non-small cell lung cancer, often called NSCLC, is another major focus of the trial program.[1] The studies include metastatic disease, newly diagnosed resectable disease, and previously treated disease with specific genetic changes such as EGFR mutations or other genomic alterations.[1]
One Phase 3 study compares Sacituzumab Tirumotecan with pembrolizumab against pembrolizumab alone in metastatic NSCLC, and the main endpoint is overall survival.[1] Another Phase 3 study in previously treated or metastatic nonsquamous NSCLC with EGFR mutations or other genomic alterations compares MK-2870 with chemotherapy and measures progression-free survival and overall survival.[1]
There is also a Phase 3 study in newly diagnosed resectable stage II, IIIA, or IIIB NSCLC with nodal involvement.[1] This trial compares MK-2870 plus pembrolizumab with pembrolizumab alone and measures disease-free survival, which means time before the cancer comes back after treatment.[1]
Another Phase 3 study in treatment-naïve metastatic squamous NSCLC compares pembrolizumab with or without maintenance MK-2870 and measures overall survival.[1] A Phase 1 study in advanced esophageal squamous cell carcinoma also includes MK-2870 in combination treatment testing, with a focus on safety and objective response rate.[1]
Gynecologic cancer studies
The trial list includes studies in ovarian, endometrial, and cervical cancers.[1] These studies focus on advanced, recurrent, persistent, or metastatic disease, which means the cancer has come back, spread, or is harder to treat.[1]
In recurrent ovarian cancer, one Phase 3 study tests Sacituzumab Tirumotecan maintenance treatment with or without bevacizumab against standard care and measures progression-free survival.[1] The same trial also has an early part that checks safety and tolerability by counting adverse events and treatment stops due to side effects.[1]
Another ovarian cancer Phase 3 study compares sac-TMT maintenance treatment with or without bevacizumab to standard care and also measures progression-free survival.[1] These studies are focused on maintenance treatment, which means treatment given after the first phase of therapy to help keep the cancer under control.[1]
In endometrial cancer, one Phase 3 study looks at pMMR endometrial carcinoma and compares Sacituzumab Tirumotecan plus pembrolizumab with pembrolizumab alone during maintenance treatment.[1] Another Phase 3 study includes post-platinum and post-immunotherapy endometrial cancer and compares MK-2870 with treatment of physician’s choice using progression-free survival and overall survival as the main endpoints.[1]
A Phase 3 cervical cancer study includes people with persistent, recurrent, or newly diagnosed metastatic cervical cancer with PD-L1 CPS greater than or equal to 1.[1] It studies maintenance treatment with Sacituzumab Tirumotecan plus pembrolizumab, with or without bevacizumab, and measures progression-free survival and overall survival.[1]
Gastrointestinal cancer studies
Several studies investigate Sacituzumab Tirumotecan in gastrointestinal cancers, including gastric, gastroesophageal junction, esophageal adenocarcinoma, colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, and gastroesophageal adenocarcinoma.[1]
One Phase 3 study in advanced or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma compares MK-2870 with treatment of physician’s choice and uses overall survival as the main endpoint.[1]
Two Phase 1 substudy trials in gastroesophageal cancer test combination treatments and focus first on safety lead-in, which is the early part of a study that checks whether a treatment can be given safely before moving to more detailed testing.[1] These studies measure dose-limiting toxicities, adverse events, treatment discontinuation because of adverse events, and objective response rate.[1]
A Phase 1 study in colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer also tests MK-2870 alone or with other anticancer agents and looks at safety and objective response rate.[1]
Urothelial and other cancer studies
One Phase 3 study in locally advanced or metastatic urothelial carcinoma compares Sacituzumab Tirumotecan with investigator’s choice nonplatinum chemotherapy and measures overall survival.[1] This means the study is checking whether MK-2870 can help people live longer than the usual nonplatinum chemotherapy options chosen by the study doctor.[1]
There is also a Phase 1/2 study in advanced urothelial carcinoma that tests MK-2870 with enfortumab vedotin and pembrolizumab.[1] The early part checks safety, and the later part also looks at objective response rate.[1]
The broader trial list also includes studies in esophageal cancer and other solid tumors, showing that the research program is exploring more than one cancer type and more than one treatment combination.[1]
Main endpoints and what they mean
The most common endpoint in these trials is progression-free survival, which measures how long the cancer does not get worse.[1] Many trials also use overall survival, which is the time people stay alive after starting treatment.[1]
Some studies measure objective response rate, which shows how many people have their cancer shrink or disappear on scans.[1] Others use disease-free survival, event-free survival, or pathological complete response, especially in studies around surgery or early treatment.[1]
Early-phase studies also track dose-limiting toxicities, adverse events, and treatment discontinuation because of adverse events.[1] These safety measures help researchers understand whether a treatment combination can be given safely before it is tested in larger groups.[1]
