Theratechnologies Inc T.TH

Interesting Context from Jones Research

[SPCEO1]

For reference, Trodelvy was approved with a 31% ORR (4%

CR; 27% PR) in TNBC and Elahere was approved with a 32% ORR (5% CR;

27% PR) in FR-alpha+ platinum resistant ovarian cancer. With respect to safety,

the construct appears better tolerated than both chemo and approved ADCs.

Specifically, grade 3 or greater TRAEs were reported at a rate of ≤12%, while

the Phase III ASCENT trial of Trodelvy saw grade ≥3 TRAEs of 11% for diarrhea

(<1% for chemo), 52% for neutropenia (33% for chemo), 8% for anemia (5% for

chemo), and 6% for febrile neutropenia (2% for chemo). In our call, management

highlighted the notable lack of both neutropenia and alopecia in patients treated

with sudocetaxel zendusortide as indicative of the improved safety profile of

the drug. Management also reiterated that the protocol amendment is expected

to focus the trial on one or two indications that sudocetaxel zendusortide is

most likely to succeed in. Given the data presented so far, we find it likely that

this will include ovarian cancer and/or TNBC. If this proves to be the case,

we anticipate adjusting our model to replace endometrial cancer with TNBC.

Notably, ~289,000 patients are diagnosed with TNBC vs ~66,000 patients with

endometrial cancer. If TNBC is, in fact, included in the amended trial, we expect

to provide a more detailed analysis of which of these patients we believe are

most likely to benefit from THTX's ADC.

[jfm1330]

This context is not great for TH1902. They are nowhere near 30% ORR, in fact they are at 5.5% (2 PR out of 36 patients). I still doubt docetaxel as cytotoxic agent. There is lot of patients resistants to it. Also, let's see if they will really enroll patients biopsy tested recently for high sortilin overexpression on their tumors. Good patient selection is critical in targeted therapies like

[SPCEO1]

Just a heads up on your comment - 36 patients were dosed but only 25 were apparantly evaluable. So, the numbers are slightly better. Still, good points. 

[Mannequin]

Fred is right.  They need to test for it

[Wino115]

Marsolais has been clear about "patient selection criteria" being modified but not sure what combination of tumor type, pre-treatment or resistance catagories or sort1 expressions either individually or by using those tissue sample traits where specific sub-types of specific tumor types showed differnet expression levels. I'm guessing the latter will be what informs them --they will

[jfm1330]

I still believe in the concept, but many times here I expressed my concerns about docetaxel, about the linker and about the absence of real patient selection based on biopsies. I don't want to hear about their data on samples of tumors from tissue banks. Selection has to be made by a biopsy of the tumor of the actual patient.  But the problem they have, is the money. It's not a new

[Wino115]

It will be interesting to hear their restart plan. You could do something cheaply that's small and focused, maybe get somr UQAM money for the TNBC part if you include that, cut some expenses elsewhere, etc.. It's definitely an issue, but maybe solvable as we figureed it's about $200k/enrollee and maybe some of that costs is already sunk in the sense they contracted with a few places to