Upcoming Gastrointestinal Readouts - New AGEN Data at ASCO-GI 2023!
- BPIQ
- Jan 18, 2023
- 3 min read
Summary
Recently we posted an article about upcoming gastro readouts including those at ASCO-GI and the upcoming MRK & SGEN PDUFA - HERE
One readout coming at ASCO-GI is from AGEN's lead asset botensilimab (anti-CTLA-4) in combination with AGEN's anti-PD1 (balstilimab)
Botensilimab is currently in a Phase 2 trial, and the ASCO-GI presentation will include expanded data from the Phase 1a/1b trial expansion cohort
Here we look at how the Bot/Bal combo data has looked in the AGEN Phase 1 trial thus far, and how it compares to CRC standard of care
If you're an Amp subscriber read our current Amp view on AGEN HERE! Contact support@BPIQ.com if you want to upgrade to get access to Amp articles, portfolios, and trades.
Botensilimab is a multifunctional Fc-engineered next generation anti-CTLA-4 antibody that is currently in multiple Phase 2 studies for solid tumors. See Figure 1 for details re: botensilimab. It differs from first generation anti-CTLA-4s by having a modified constant region of the antibody that is designed to increase its activity and decrease AEs.
FIG. 1
Previously data for Botensilimab in combo with balstilimab (Bot/Bal) trials have been presented at ESMO-GI 2022, CTOS 2022 and SITC 2022. The Bot/Bal combo has been shown to be superior to standard of care across multiple tumor types (See Figure 2 for multiple indications and Figure 3 for specific CRC data). The Bot/Bal combo has shown to have a better Overall Response Rate, Disease Control Rate, and median Progression Free Survival than all other combos compared, even when treating patients that have gone through more prior lines of therapy. The Bot/Bal combo showed very encouraging durability and tolerability in these patients.
The overall response of Botensilimab in solid tumors as well as MSS-CRC specifically is impressive, with a 4-10 fold increase in overall response rate compared to the current standard of care. Data from this expansion trial was also presented at SITC in November 2022 (included in a presentation about responses in nine different treatment-resistant cancers). 59 patients from the MSS-CRC study were involved in the SITC presentation and there was a 22% ORR.
Overall response rate - 22%
Disease control rate - 73%
Median duration of response not reached - 69% of responses ongoing
Median progression free survival - 4.1 months
Based on the positive data that have been presented thus far for this Phase 1 trial, Botensilimab is currently in a Phase 2 study (ACTIVATE) for MSS CRC.
FIG. 2
FIG. 3
See Figure 4 for data comparing Bot/Bal with other combos to treat CRC.
The Bot/Bal combination looks more tolerable than most anti-CTLA4 combinations, but there are still grade 3/4 AEs. For example, in the Bot/Bal combination expansion cohorts there was one instance of Grade 4 colitis, and there were 48 cases (38%) of any grade. The data coming up at ASCO-GI is from the same trial presented at SITC 2022, but more data from these patients will be presented. It will be interesting the see if the updated CRC data to be presented at ASCO-GI still looks much better than the current standard of care (See Figure 4), updated duration of response data, and whether there are more Grade 3/4 AEs that pop up.
AGEN is presenting a late-breaking abstract at ASCO-GI so the abstract will be available at the time of presentation (Saturday Jan 21st at 10am EST). Late breaking data was submitted by November 15, 2022. Come back for the abstract and poster after the presentation! We are very excited to see the presentation from AGEN over the weekend at ASCO-GI and hope the results continue to be successful!
FIG. 4
If you're an Amp subscriber read our current Amp view on AGEN HERE! Contact support@BPIQ.com if you want to upgrade to get access to Amp articles, portfolios, and trades.
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 1/18/2023, updated 1/19/23
Comments