Hi Bavarian
The abstract gives us the Overall Response Rate data for all 12 of the patient in the dose escalation study - and those are indeed excellent results. To be included in the trial patients had to have Stage IIIb non-small-cell lung cancer. They also had to have active/progressive disease despite already already being treated with a PD1 or PD-L1 Checkpoint Inhibitor. ie. They had already failed treatment with a PD1 drug. These were very very unwell people....
The results are great - and that is with PD1-vaxx as a mono therapy. It was always intended to be used in combination therapy, so we can reasonably expect even better results in the current trial in combination with Tecentriq (Atezolizumab).
However the same Overall Response Rate data was already released/publicised back in May when an abstract of a paper for the ASCO 2022 Annual Meeting was published on the ASCO website
. Imugene announced it on 27 May. They didn't quote the data but they did give a link to the Abstract which contain the data:
https://meetings.asco.org/abstracts-presentations/212919So the ORR data - though very good - is not new. I would think the "new PD1-vaxx data" referred to in the Announcement of 13 July would be the data on Progression Free Survival and Overall Survival - both of which are secondary outcome measures in the trial. We have been told several times that some of the patients are still living - one of them from Cohort 1 and now 2 years down the track. They also list Humoral Immungenicity and Cellular Immungenicity a "other outcome measures."
I suppose it is also possible that there will be some kind of Announcement about the next step - which is the combination trial with Tecentriq. However, so far as I can see there has been no Announcement yet to tell us that the combination trial has actually commenced. Unless I have missed something? All we have heard about it was the Announcement back on 28 January this year to tell us about the Tecentriq supply agreement with Roche and snce then silence - except for a mention in the March Quarterly released on 22 April which stated that "PD1 Vaxx has completed its Phase 1a monotherapy dose escalation and will proceed to combination dose escalation after review by Cohort Review Committee (CRC) Again - unless I have missed something later than that?? There was no further update in the June Quarterly.
Imugene regards the combo with Tecentriq as just an extension of the Ph 1 dose escalation trial. In their Announcements they describe it as "IMPRINTER: An open label, multicenter, dose escalation/expansion, phase 1 study of IMU‐201 (PD1‐Vaxx), a B‐cell immunotherapy as monotherapy or in combination with atezolizumab, in adults with non‐small cell lung cancer (IMU.201.101)
In the 28 January Announcement they say: "The objectives of the phase 1b trial, “An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab, in Adults with Non-Small Cell Lung Cancer,” are to determine safety, efficacy, and optimal dose of PD1-Vaxx in combination with atezolizumab as either first-line therapy in ICI treatment- naïve NSCLC patients or ICI pretreated patients. The study will be conducted at sites in USA and Australia."
The trial description on ClinicalTrials.gov has not been updated since January 20th, so it does even mention Tecentriq/Atezolizumab specifically. It just says: "Once the monotherapy optimal biological dose is established and expansion complete, the protocol will be modified to include a combination dose escalation with standard of care treatment.". Source:
https://clinicaltrials.gov/ct2/show/NCT04432207?term=IMU-201&draw=2&rank=1So - has the combination arm of the study actually commenced yet? Who knows? I hope we find out tomorrow - but the results of PD1-vaxx as a monotherapy really are excellent in my opinion, and the results in combo with Tecentriq would be even better.
Cheers
Dave
(20min delay)