I really value and appreciate the Q&A section of the ann which Race has made a habit of including for the benefit of explaining important aspects of the trial design and help novices like me get just a little bit more understanding of the results in layman's terms. I am extracting and interpreting the following sections (
blue text) from today's ann in my own words - please correct me if I misunderstood anything.
"Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses ofintensive chemotherapy. (this means patients who have received more courses (lines) of chemo have even lesser chance of survival!). Even when CR is achieved through intense chemotherapy, approximately half of theyounger and 80% of the older patients, relapse (so getting a Complete Response is phenomenal!). In both clinical situations, refractoryand/or relapsed AML, active disease remains a major therapeutic challenge despiterecent advances in the clinic.
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Each cycle of treatment a cancer patient experiences and failsincreases the risk of general resistance developing. For example, a treatment that maywork in 70% of first line patients may only work in 5% of 6th line patients. As treatmentrounds progress the patients become less and less likely to respond to any newtreatment."
Before you forget it, Zantrene had 75% response in "heavily pre-treated patients". How much chemo they had before?
"This first stage requires identifying the treatment dose level that achievestwo or fewer dose-limiting toxicities (DLTs) from six consecutively treated patients. In theinitial six patients treated, two DLTs were reported (one Grade 3 elevated liver enzymesand one Grade 5 infection). Both DLTs occurred in the most heavily pre-treated patientswho had received five and eight prior lines of treatment, respectively." So these patients had 5 to 8 lines (rounds) of chemo prior to being enrolled on this trial. So the results are OFF THE CHARTS!
"Patients in previous Phase 2 trial of Zantrene used as a single agent showed an overallclinical response rate of 40% (ASX Announcement: 16 June 2020). The patients in the earlytrial had a median of three prior lines of treatment. In the subgroup of patients from thecurrent triple combination study who had received a similar number of prior treatmentlines, the response rate appears higher (3 out of 4)."Despite such challenging odds, here is what Zantrene achieved: 3 out of 4 patients has responded to the treatment: 1 had Complete Response and 2 patients had Partial Response.
That is a 75% response as a combination treatment compared to 40% response in the Sheba Trial 1 in 2020 when Zantrene was used as a single agent. This is highly relevant per this important point that Dr.T tweeted:
Now you know why Zantrene is valuable? It has 40% response as a single agent and 75% response in a combination chemotherapy. This is relevant because:
1. It proves that Zantrene on its own has cancer-fighting capability
2. When used in combination with other standard of care (SOC) drugs enhances the patient outcomes.
3. The treating doctors are familiar with the SOC drugs so they would be more inclined to use with them rather than as single agent, especially when the combination result is 75% vs 40% for single agent
4. Last but not the least, SOC are owned by BP who would love to partner/ license/ own Zantrene!
The juiciest part comes next which is the Australian EMD AML trial which has the on-site training on 31/5 and enrolment starting soon after! Here is an extract from the EMD AML trial design:
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As the patient population is considered to have no existing treatment options, a comparator arm will not be used."
With a 75% response seen in R/R AML per today's ann, there will be a lot of hope for these patients in the Australian EMD AML trial particularly as there have no other treatment options left. Isn't it great that Race can provide some hope of survival for these patients and their families? I get goose bumps as I type this. Is there any doubt that we will have difficulty recruiting patients for this trial despite it being a rare condition? I think not.
(20min delay)