Upcoming Gastrointestinal Cancer Events - PDUFA and Conference this Week!
- BPIQ
- Jan 17, 2023
- 3 min read
Article currently in progress (1/17/23)
Summary:
ASCO-GI starts this Thursday, January 19, 2023
This conference focuses on indications including stomach cancer, gastrointestinal cancer, esophageal cancer, and colorectal cancer (https://conferences.asco.org/gi/program)
In past years, big readouts have happened at this conference including from several Phase 3 trials
On Thursday Jan 19 there is also a PDUFA for a GI indication: the SGEN and MRK PDUFA for Tukysa (Tucatinib) to treat mCRC
With the ASCO-GI conference (Jan 19-21, 2023) and a colorectal cancer PDUFA coming up this week, gastrointestinal cancers are in the spotlight this week. ASCO-GI focuses on gastric cancers that include gastrointestinal cancer, gastroesophageal cancer, stomach cancer, colorectal cancers, and other solid tumors in the GI tract. Several smid-cap biopharma companies have reported their participation at ASCO-GI 2023, and as with past years we expect additional companies to provide info on their involvement during the several days of presentations.
Abstracts for all presentations at ASCO-GI besides late breaking presentations were released TODAY (Jan 17) at 5pm EST and we will continue to update this article as we learn about additional presentations.
In past years, companies have announced data at ASCO-GI including:
CYAD: CYAD-101 Ph1 prelim data for mCRC at ASCO-GI 2022
CRDF: Onvansertib updated Ph1b mCRC data at ASCO-GI 2022
HCM: Elunate in CRC Ph1/1b data at ASCO-GI 2022
NCNA: NUC-3373 CRC Ph1 data at ASCO GI 2021
RCUS: Quemliclustat pancreatic adenocarcinoma Ph1 data at ASCO-GI 2021
AGIO: Tibsovo in AML Ph3 data at ASCO-GI 2021
MGNX: MARGENZA Ph3 in metastatic breast cancer at ASCO-GI 2019
We have compiled a list of upcoming events in GI cancers - several which are presenting at ASCO-GI and others with readouts later in 2023. See Table 1 for this list of upcoming events.
Both ASCO-GI and the SGEN/MRK PDUFA are happening this Thursday, making it a big day for gastric cancer indications. Gastrointestinal cancers involve tumors in the pancreas, colon, stomach, esophagus, rectum, small intestine, and other gastric regions. CRC is a specific type of GI cancer, and “Tumors in the stomach, liver, colon and rectum are among the five most common cancers in both men and women worldwide”. https://www.uchicagomedicine.org/forefront/gastrointestinal-articles/inherited-gastrointestinal-cancer
Currently, treatments for CRC include surgery, chemotherapy, and radiation. This is a very important market then for these upcoming readouts.
See Table 1 for important upcoming GI (including CRC) readouts in 2023.
Table 1. Upcoming GI readouts in 2023
Gastrointestinal Cancer Company Focus:
SGEN
The SGEN/MRK PDUFA for CRC on Thursday could be the first approved product for colorectal cancer. The PDUFA is for TUKYSA (tucatinib) in combo with trastuzumab to treat HER2+ mCRC. The submission of the sNDA was based on the Phase 2 MOUNTAINEER trial that was reported in mid 2022. The Phase 3 MOUNTAINEER-03 confirmatory trial is also evaluating Tucatinib + trastuzumab and chemotherapy.
Tucatinib is an oral tyrosine kinase inhibitor of the HER2 protein and is currently approved for certain HER2+ metastatic breast cancers.
AGEN
Phase 1a/1b trial results of Botensilimab will be presented at ASCO-GI from Jan 19-21, 2023. Botensilimab is in trials to treat metastatic heavily pretreated microsatellite stable colorectal cancer (MSS CRC). A Phase 2 trial (ACTIVATE) of Botensilimab was initiated in Q3 2022 and the ASCO-GI presentation will include expanded data of botensilimab + balstilimab from the Phase 1 trial. This is a late breaking presentation at ASCO-GI and will occur Sat Jan 21 at 10am EST.
ZYME
ZYME’s asset Zanidatamab is in trials for several GI cancers including biliary tract cancer, gastroesophageal adenocarcinoma, and HER2- expressing cancers. Additional data from the Ph2 trial in GEA cancer will be presented at ASCO-GI 2023. This trial is a triple combo trial of Zanidatamab + chemo + tislelizumab. A Phase 3 trial of Zanidatamab as a monotherapy is also ongoing (HERIZON-GEA-01) with updates in late 2023.
GTHX
Phase 3 data from the Trilaciclib trial in CRC is expected in February and is a BPIQ Suspected Mover. The Phase 3 PRESERVE 1 trial in CRC initiated at the end of 2020 and this would be the first data from the CRC cohort. Trilaciclib is approved to treat small cell lung cancer under the name COSELA and is in trials for breast cancer and bladder cancer as well as colorectal cancer. Trilaciclib is a small molecule inhibitor of cyclin dependent kinases 4 and 6.
Come back regularly as we add additional companies to this article that are presenting at ASCO-GI 2023.
This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.
Article history:
Originally posted 1/17/2023
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