Imugene Ltd (ASX:IMU, OTC:IUGNF) earlier this week reported new clinical data from its Phase 1b trial evaluating azer-cel in patients with diffuse large B-cell lymphoma (DLBCL), including those who had previously failed CAR-T therapies.
The company said the trial has achieved an 82% overall response rate in the CAR-T-fail population, with every patient experiencing either a complete response or partial response. A complete response means no detectable cancer, while a partial response involves a reduction of at least 50% in tumour burden.
Imugene highlighted that some patients initially recorded as partial responders have now converted to complete responders. It said this aligns with the typical time frame for CAR-T treatments, where maximum response can take two to three months to materialise.
In a second cohort made up of CAR-T-naive patients, the company reported an 83% response rate. It said that enrolment in this group has more than tripled since it was opened, reflecting strong interest in the therapy among patients who have not received prior CAR-T treatment.
Imugene also said that the first patient dosed in 2024 remains in complete response more than 19 months after treatment. The company noted that many participants had undergone between two and six previous lines of therapy before enrolling in the trial.
Some of these patients have since become eligible for allogeneic stem cell transplants, which Imugene said could be curative in certain cases. It added that this potential next step may provide additional benefit for responders to azer-cel plus IL-2.
The company said it recently held a positive meeting with the FDA and expects to receive the official meeting minutes within approximately 30 days. It said it plans to announce the outcome once those minutes are received.
Imugene is continuing enrolment and monitoring in both patient cohorts and intends to provide further updates as data matures.
Proactive:
Welcome back to Proactive Newsroom. I'm now joined by Imugene CEO Leslie Chong. Welcome back, Leslie — it's good to have you.
Leslie Chong:
Thanks so much for having me.
Proactive:
Leslie, the response rate for Phase 1b evaluating azer-cel against a pretty aggressive type of blood cancer has now gone up to 82%. Can you tell us more about that?
Leslie Chong:
Absolutely. This is an 82% overall response rate, meaning patients have had either a complete response or a partial response. A complete response means no tumours or disease detected in scans. A partial response means at least 50% of their cancer was reduced.
Every patient that has come into this CAR-T-fail population with DLBCL — diffuse large B-cell lymphoma — has had either a CR or a PR. So that’s 82% of those patients.
Proactive:
So Leslie, you've got some patients who initially had a partial response. Have any of them converted to a complete response?
Leslie Chong:
I’m happy to note that we have. For approved CAR-Ts, it usually takes two to three months for patients to achieve their best response. Sometimes T cells need time to work — especially in this aggressive, large tumour population. So it can take a few months for the cancer to fully clear.
Proactive:
What about the cohort who haven't been treated with CAR-T before? What's happened with them?
Leslie Chong:
That’s our CAR-T-naive population. We recently reported an 83% response rate there. Every patient so far has seen a complete or partial response.
These are well-treated patients, but many haven’t had access to CAR-T because it wasn’t approved or they opted into our study instead. We’ve seen strong interest — enrollment in that cohort has more than tripled since it opened.
Proactive:
And notably, I believe the first patient dosed in 2024 has remained cancer-free for over 19 months?
Leslie Chong:
Yes — in the CAR-T-fail population, the first patient dosed with azer-cel plus IL-2 had a complete response and has maintained that for over 19 months.
Others have also achieved CRs or PRs. Many of these patients went through two to six prior therapies, including autologous CAR-Ts. Now, some have qualified for an allogeneic transplant, which could be additive or potentially curative.
Proactive:
It’s been quite a busy quarter, Leslie. We’re just three weeks away from Christmas — what’s next for Imugene?
Leslie Chong:
We had a positive meeting with the FDA recently. It usually takes about 30 days to receive the meeting minutes. I’m very excited to announce the outcome as soon as we receive them.
Proactive:
We'll look forward to having more updates from you, hopefully before the end of the year. This was Imugene CEO Leslie Chong — thank you for your time.
Leslie Chong:
Thank you for having me.