Replies to post #46231 on OncoSec Medical Inc (ONCSQ)

[kykkern]

The ONCS Compensation Board don't have time to reply, they focus on what they do best;

Creating Value for Management

[dangerM]

> I asked if the statistical assumptions behind the changed trial design has been made public anywhere.

We have them now on slide 16 of the current corporate presentation (https://oncosec.com/wp-content/uploads/2019/02/ONCS-Corporate-Presentation_Feb-2019-compressed.pdf) together with a general status update:

- ORR Tracking at ~24%
- Study size of ~100 to enable potential detection of clinically
meaningful response rate (>or=20 %) with a 95% confidence interval
- 2 of the responding patients no longer being treated with TAVO
because there are no TAVO accessible lesions
- Currently ~33 treated, 21 evaluated and 16 patients on study

With the lower bar (20% instead of 30% previously assumed for the two-stage design) this makes a sucess of the trial more probable.

One should also note the composition, cf. the Pisces trial poster from SITC 2018 which showed that of the first N = 21 enrolled patients, there were (patient numbers in parentheses)

stage III (3)
stage IVA (10)
stage IVB (5)
stage IVC (3)

Please, if anyone compares the Pisces data to date to other trials, bear that in mind: we have immunotherapy failures in melanoma with the majority at stage IV.

I must admit when Robert Coffin the inventor of T-Vec (Imlytic) recently posted a link to the real world usage of it, I was shocked at first and thought that's the end of nearly all treatments in development (phew, good that was only the first thought). See yourself, from the abstract:

https://www.ncbi.nlm.nih.gov/pubmed/30694555

Int J Cancer. 2019 Jan 29. doi: 10.1002/ijc.32172.

High Response Rates for T-VEC in Early Metastatic Melanoma (Stage IIIB/C-IVM1a).
Franke V1, Berger DMS2, Klop WMC2, van der Hiel B3, van de Wiel BA4, Ter Meulen S1, Wouters MWJM1, van Houdt WJ1, van Akkooi ACJ1.

The phase 3 OPTiM registration study showed an overall response rate (ORR) of 26%. ... [But then in real world use:] Of 26 patients, 16 (61.5%) had a Complete Response (CR) as their best response. Seven (26.9%) patients had a Partial Response (PR) as their best response, 1 (3.8%) patient Stable Disease (SD) and 2 (7.7%) patients Progressive Disease (PD). Best ORR was 88.5%.

How can that be, 88.5% ORR and even 61.5% were complete responders for Imlytic? In a way the answer is already in the above quoted sentences, namely in the 26% ORR for Imlytics registrational trial. Those 88.5% ORR for the real world use apply to stages IIIB (14) and IIIC (12) patients of which only a single patient had prior BRAF/MEKi exposure and another single one some prior Ipi/Nivo therapy. I.e. the majority of those patients would not have been eligible to take part in the Pisces trial! They would have been told to try e.g. pembro alone and only return if not responding to it.

That's it for the data update. Seems we have to wait a bit now for the next conference.

Sigh (argh, the market)