Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy.

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Theratechnologies Inc > Trodelvy's most direct competitor in TNBC Ph 1 data released

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Comment by qwerty22on Dec 08, 2021 10:26pm

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Post# 34213107

RE:Trodelvy's most direct competitor in TNBC Ph 1 data released

Here's a different ADC that got approved a few months ago for recurrent cervical cancer. This had an ORR of 24%, average DOR of 8.3 months. Some patients got >36 months when expectation were max 12 months for anybody with this diagnosis.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer

Shows with cancers with limited options you can get an approval with lower numbers. Paul emphasized the presence of a couple of patients with cancers with unmet medical needs.

Wino115 wrote:

Here’s some Phase 1 results from the drug most see as the nearest direct competitor in TNBC to Trodelvy at this point (because TH1902 is not very well known!). It’s from Daiichi Sankyo and Astra Zeneca and called DS-1062.

Data is from cutoff of Jul30 and for 44 TNBC patient cohort of the TROPION study. Recall it’s a Topo1 inhibitor ADC.

—-Objective Response Rate was 32% — in line with Trodelvy

—- Disease Control Rate was 77% (disease control is total of complete, partial and stable disease).

—- In TOPO-1 ADC Naive subset, ORR was 48% —better than Trodelvy in apples-to-apples cohort

—- Baseline had 11% with brain metastases, 68% 2 prior lines, 30% treated with TOPO-1 ADCs

—- Disease Control “observed” beyond 7 months in patients with ongoing response

—- No median Duration of Response reached at current date cutoff

Safety Summary:

—-Grade 3 or higher TEAE’s in 23% (TEAE = Treatment Emergent Adverse Event)

—- Serious treatment related TEAE’s in 5%

—- Common ones of nausea, stomatitis in 50-60%

So seems the hurdle to beat is still around 35% ORR or maybe 50% ORR for those with high sortilin expression (so it’s proper cohort) and having a disease control rate that’s pretty high —so at least a bunch of stables and some partial and complete responses of 50% or hugher.