Immunomedics Announces Encouraging Early-Stage Clinical Results with Trodelvy™ in Brain Cancers
September 18 2020 - 8:00AM
Immunomedics, Inc. (NASDAQ: IMMU)
(“Immunomedics” or the “Company”), a leading biopharmaceutical
company in the area of antibody-drug conjugates, today announced
that Trodelvy delivered 150-fold and 40-fold the 50% inhibitory
concentration (IC50) of SN-38 for BMBC and rGBM, respectively, and
produced partial responses in both cohorts of brain cancer
patients.
“These early intracranial responses are very
encouraging signs of sacituzumab govitecan’s activity in central
nervous system (CNS) tumors as previously observed in preclinical
models,”1 said Andrew J. Brenner, M.D. Ph.D., Clinical
Investigator, Institute for Drug Development; Co-Leader,
Experimental and Developmental Therapeutics Program; S & B
Kolitz/CTRC-Zachry Endowed Chair in Neuro-Oncology Research, Mays
Cancer Center at UT Health San Antonio, San Antonio, TX, who
reported the results in a mini oral session on CNS tumors at the
ESMO Virtual Congress 2020. “With a hydrolysable linker that allows
SN-38 to be released at the tumor site and given that SN-38 freely
crosses the blood brain barrier and is active in the nanomolar
range for most cancer cells, including triple-negative breast
cancer (TNBC) and GBM, sacituzumab govitecan has the prerequisite
ability to deliver therapeutically relevant concentrations of SN-38
across an undisrupted vasculature. The early clinical results in
patients with neoplastic involvement of the brain warrant further
development of Trodelvy in these aggressive and lethal
cancers.”
At the time of data cutoff, 19 patients (7 BMBC
and 12 rGBM) were enrolled into the study. Key clinical data from
evaluable patients are summarized below. No new safety signals were
observed.
|
BMBC |
rGBM |
Tumor response*, N |
7 |
7 |
Partial response, n |
2 |
2 |
Ongoing progression-free survival, n (range) |
4 (161-279 days) |
6 (7-315 days) |
Residual measurable disease, n |
4 |
7 |
Tumor SN-38 concentrations, N |
4 |
6 |
Mean total SN-38 (nM) (range) |
455 (174-1,160) |
270 (93-687) |
Mean free SN-38 (nM) (range) |
73 (15-198) |
46 (20-90) |
SN-38G# detected in 1 patient in each cohort (nM) |
3.4 |
5.8 |
* Per RANO criteria, # SN-38 glucuronide, an
inactive metabolite of SN-38 |
“Brain metastasis is a significant concern in
patients with TNBC, and we are very encouraged by these early-stage
study results,” stated Dr. Loretta M. Itri, Chief Medical Officer
of Immunomedics. “Additionally, given that GBM is a disease with
great unmet need, we are working in close collaboration with Dr.
Brenner and others, including the Southwestern Oncology Group, to
design programs that could potentially elucidate the role of
Trodelvy in the management of BMBC and rGBM.”
Patients with BMBC or rGBM were enrolled into
the single center study (NCT03995706) to receive a single
intravenous dose of Trodelvy at 10 mg/kg one day before surgical
resection. Tumor and corresponding serum were collected during
surgery to measure their levels of SN-38 and its metabolites.
Following recovery, patients resumed Trodelvy treatment at 10 mg/kg
on days 1 and 8 of 21-day cycles and were assessed for responses by
MRI every third cycle using response assessment in neuro-oncology
(RANO) criteria.
About Brain Cancer
According to the National Cancer Institute
(NCI), an estimated 23,890 American will be diagnosed with brain
cancer in 2020 and about 18,020 people will die from the disease in
the U.S. this year.2 Among the numerous brain tumor types,
glioblastoma (GBM) is the most aggressive, with median
progression-free survival (PFS) and median overall survival (OS)
from diagnosis of 6.2-7.5 months and 14.6-16.7 months,
respectively, having been reported in clinical trials.3-6 For
patients with recurrent GBM, chemotherapy regimens are associated
with overall response rates of 4-9%, 6‑month PFS of 10-19%, and
median OS of 5-10 months.7–11
References
- Pandey R, Gruslova A, Chiou J, et al. Stable isotope dilution
LC-HRMS assay to determine free SN-38, total SN-38, and SN-38G in a
tumor xenograft model after intravenous administration of
antibody−drug conjugate (sacituzumab govitecan). Anal Chem.
2020;92(1):1260-1267.
- https://seer.cancer.gov/statfacts/html/brain.html Accessed on
September 17, 2020.
- Stupp R, Mason WP, van den Bent MJ, et al. European
Organisation for Research and Treatment of Cancer Brain Tumor and
Radiotherapy Groups; National Cancer Institute of Canada Clinical
Trials Group. Radiotherapy plus concomitant and adjuvant
temozolomide for glioblastoma. N Engl J Med.
2005;352(10):987-996.
- Gilbert MR, Dignam JJ, Armstrong TS, et al. A randomized trial
of bevacizumab for newly diagnosed glioblastoma. N Engl J Med.
2014;370 (8):699-708.
- Gilbert MR, Wang M, Aldape KD, et al. Dose-dense temozolomide
for newly diagnosed glioblastoma: a randomized phase III clinical
trial. J Clin Oncol. 2013;31(32):4085-4091.
- Chinot OL, Wick W, Mason W, et al. Bevacizumab plus
radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl
J Med. 2014;370 (8):709-722.
- Wong ET, Hess KR, Gleason MJ, et al. Outcomes and prognostic
factors in recurrent glioma patients enrolled onto phase II
clinical trials. J. Clin. Oncol. 17, 2572–2578 (1999).
- van den Bent MJ, Brandes AA, Rampling R, et al. Randomized
phase II trial of erlotinib versus temozolomide or carmustine in
recurrent glioblastoma: EORTC brain tumor group study 26034. J.
Clin. Oncol. 27, 1268–1274 (2009).
- Batchelor TT, Mulholland P, Neyns B, et al. Phase III
randomized trial comparing the efficacy of cediranib as
monotherapy, and in combination with lomustine, versus lomustine
alone in patients with recurrent glioblastoma. J. Clin. Oncol. 31,
3212–3218 (2013).
- Wick W, Puduvalli VK, Chamberlain MC, et al. Phase III study of
enzastaurin compared with lomustine in the treatment of recurrent
intracranial glioblastoma. J. Clin. Oncol. 28, 1168–1174
(2010).
- Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent
bevacizumab or lomustine versus a combination of bevacizumab plus
lomustine in patients with recurrent glioblastoma (BELOB trial): a
randomised controlled phase 2 trial. Lancet Oncol. 15, 943–953
(2014).
About Immunomedics
Immunomedics is a leader in next-generation
antibody-drug conjugate (ADC) technology, committed to help
transform the lives of people with hard-to-treat cancers. Our
proprietary ADC platform centers on using a novel linker that does
not require an enzyme to release the payload to deliver an active
drug inside the tumor cell and the tumor microenvironment, thereby
producing a bystander effect. Trodelvy, our lead ADC, is the first
ADC the FDA has approved for the treatment of people with
metastatic triple-negative breast cancer and is also the first
FDA-approved anti-Trop-2 ADC. For additional information on the
Company, please visit its website at https://immunomedics.com/. The
information on its website does not, however, form a part of this
press release.
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For More Information:
Dr. Chau Cheng(862)
260-3727ccheng@immunomedics.com
For Media Inquiries:
Darren Opland, Ph.D.(646)
627-8387Darren@lifescipublicrelations.com
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