Interesting Context from Jones Research 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.