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| Statement |
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| And the third was the strong support from the FDA for the first-line clinical development plan |
| And after discussing the clinical and underlying mechanism with the FDA, in June of last year, we received strong support for the decision to move our program to the first-line setting |
| And importantly, when we look at the safety data that is included in the appendix of this material, we see that onvansertib when combined with chemotherapy plus bev is well-tolerated with no major unexpected toxicity that was observed |
| As we state on slide eight, we discussed our findings, including both the Phase 1b/2 clinical data and the new mechanism of action I mentioned at the start of the call, with the FDA, which led to their strong support for us to discontinue to ONSEMBLE trial and shift our clinical program to the first-line setting |
| This is highly encouraging and consistent with what we would have expected based on our prior Phase 1/b2 trial data |
| However, as the Phase 1b/2 data matured, we saw a powerful and unexpected positive signal from the data |
| For all these reasons, we continue to believe our shift to the first-line setting is the best strategy for all of our stakeholders, particularly the large number of patients, 48,000 per year in the U.S |
| Mark, I hope you feel better soon |
| What's new today is that, for the first time, we are releasing data from our ONSEMBLE trial, adding powerful support to our first-line strategy |
| And by the end, I hope you'll agree that ONSEMBLE data adds substantial support to our first-line program |
| So, I'm looking at the swimmers plot, and even sort of considering both bev naïve and bev exposed, and it feels like there's a pretty good, even maybe emerging PFS signal that you're seeing in this randomized data |
| Our clinical operations efforts, together with Pfizer Ignite, are going well, with a critical mass of 20 clinical trial sites activated as of today |
| This mechanism of action explains why we believe we are seeing this clear efficacy signal in bev naïve patients |
| Great |
| As we discussed in detail in August, we believe that the robust responses we are seeing are due to a novel mechanism of action that we have discovered for onvansertib's role in the hypoxia response pathway |
| Thank you so much for taking all of our questions and congratulations on the progress |
| And I'm excited to show you the results of the next slide |
| As you can see, the answer to my question, the bev naïve patients receiving onvansertib with FOLFIRI/bev once again had the most robust response to treatment |
| with RAS-mutated mCRC that may benefit from a new approach to treating their disease |
| First, ONSEMBLE is the second independent and randomized dataset reproducing the robust efficacy signal for onvansertib plus standard of care in bev naïve patients |
| The Phase 1b/2 trial in KRAS-mutated mCRC generated the initial signal of efficacy on which we based our mCRC clinical development program |
| Good afternoon, everyone, and thank you for joining the call |
| Importantly, both these patients have confirmed partial responses |
| First, the ONSEMBLE trial was independent because it's a second clinical trial at a different point in time than our earlier Phase 1/b2 trial, showing once again that bev naïve patients have a strong response to therapy that includes onvansertib with FOLFIRI and bev |
| Mark Erlander Thank you |
| Mark Erlander Thank you |
| Andy Hsieh Great, thanks for taking our questions |
| Looking at the range of our announcement in 2023, you can -- we believe that the year was a truly transformational for Cardiff Oncology |
| Thank you |
| The first was the clinical signal from our second-line mCRC trial |
| Statement |
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| I believe I'm losing my voice |
| Turning now to slide 23, you can see that colorectal cancer is a major public health issue |
| The PI has moved to another academic institution and so that has somewhat slowed down the accrual in that particular trial |
| Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties |
| But we agree with you, that there looks like there is an emergent signal |
| But at this point, we don't think it's going to be a big issue |
| This reduced the treated patient population evaluable for safety to 22 patients only |
| Importantly, one patient was never treated because the patient withdrew consent and left the trial prior to receiving any therapy |
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