GLOBAL RESEARCH ARCHIVE
Biotechnology: Quick takes for key ASCO abstracts: BNTX, GILD and REGN
Research evidence excerpt
Biotechnology: Quick takes for key ASCO abstracts: BNTX, GILD and REGN
GILD: Incremental TUB-040 and Trodelvy data
GILD also provided updated ph 1/2 NAPISTAR 1-01 data for acquired TUB-040 in PROC
(Tubulis acquisition completed today). As of the 12/1/25 cutoff date, 67 patients have
been dosed with Q3W TUB-040 for a median of 10 cycles. In 46 evaluable patients
across dose levels 1.67-3.3 mg/kg, GILD reported 2 CR (4%), 26 PR (57%), 16 SD (35%)
and 2 PD (4%), representing a cORR of 60.9% (28/46). 90% of responses were ongoing
at data cutoff and DCR was 96%. On safety, TUB-040 demonstrated a consistent safety
profile with prior results. There were no fatal TEAEs or treatment discontinuations due
to TEAEs. We view today’s update as more incremental for the program in-line with prior
efficacy signals. We make no adjustments to our model at this time and cite focus on
more detailed data at the conference (rapid oral session Saturday, May 30th – 8:36-8:42
AM CT) as well as additional insight on next steps (ph 3 likely to initiate in 2027).
Abbreviations
CR: complete response
cORR: confirmed overall response rate
CRS: cytokine release syndrome
DCR: disease control rate
ESMO: European Society for Medical Oncology
irAE: immune-related adverse event
mTNBC: metastatic triple negative breast cancer
NSCLC: non-small cell lung cancer
ORR: overall response rate
OS: overall survival
PD: progressive disease
PFS2: progression-free survival after next-line treatment
Ph: phase
PR: partial response
PROC: platinum resistant ovarian cancer
Q3W: every 3 weeks
SD: stable disease
SoC: standard of care
TEAE: treatment emergent adverse event
uORR: unconfirmed overall response rate
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