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
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With ASCO-GI and the CRC PDUFA coming up, gastrointestinal cancers are in the spotlight this next 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 besides late breaking presentations were released Jan 17 at 5pm EST and we will continue to update our full ASCO-GI analysis HERE with 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
NCNA: NUC-3373 CRC Ph1 data at ASCO GI 2021
CRDF: Onvansertib updated Ph1b mCRC data at ASCO-GI 2022
AGIO: Tibsovo in AML Ph3 data at ASCO-GI 2021
MGNX: MARGENZA Ph3 in metastatic breast cancer at ASCO-GI 2019
HCM: Elunate in CRC Ph1/1b data at ASCO-GI 2022
RCUS: Quemliclustat pancreatic adenocarcinoma Ph1 data at ASCO-GI 2021
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 instine, 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.
The SGEN/MRK PDUFA for CRC on Thursday could be the first approved product for colorectal cancer. For more info on this PDUFA sign up for a free account to see our February PDUFA post or full GI asset analysis.
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Table 1. Upcoming GI readouts in 2023
Upcoming GI Data:
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.
The title of the presentation in "Results from a phase 1a/1b study of botensilimab (BOT), a novel innate/adaptive immune activator, plus balstilimab (BAL; anti-PD-1 antibody) in metastatic heavily pretreated microsatellite stable colorectal cancer (MSS CRC)." and the abstract will be released on the day of presentation (Saturday).
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