Immunomedics, Inc., (NASDAQ:IMMU)
(“Immunomedics” or the “Company”) today reported the publication in
two prominent cancer journals of phase II clinical trial results
with sacituzumab govitecan (IMMU-132) in a total of 104 patients
with lung cancer, including advanced small-cell lung cancer (SCLC)
and non-small-cell lung cancer (NSCLC) patients who relapsed after,
or were refractory to, prior treatment with standard chemotherapy
or immune checkpoint inhibitors
.
In the SCLC study published online in Clinical
Cancer Research, the authors1 evaluated the novel antibody-drug
conjugate (ADC), sacituzumab govitecan, composed of an antibody
targeting Trop-2 and carrying the active metabolite of irinotecan,
SN-38. The study included 50 SCLC patients with metastatic (stage
IV) disease who had a median of 2 prior therapies. Notable findings
from the study include:
- Ninety-two percent of the patients evaluated for expression of
the target for sacituzumab govitecan, Trop-2, had elevated levels
in their archived tumor specimens.
- Patients given repeated treatment cycles had manageable
toxicity, mostly Grade >3 neutropenia (34%), and 60% of those
patients experienced tumor shrinkage from baseline CT
measurements.
- The objective response rate was 17% at the optimal dose
schedule; the median duration of response and overall survival were
5.7 and 7.5 months, respectively.
- Activity was observed in patients who were chemosensitive or
chemoresistant to frontline chemotherapy, in patients who failed
second-line topotecan, and in a subset who relapsed after immune
checkpoint inhibitor therapy.
The article’s first author, Jhanelle Gray, M.D.,
of the Moffitt Cancer Center, Tampa, FL, remarked, “Topotecan,
another topoisomerase-I inhibitor, is the only drug approved in the
USA for SCLC patients who are responsive to frontline therapy with
a platinum-containing chemotherapy. In contrast, sacituzumab
govitecan showed activity in patients who were either responsive or
refractive to frontline therapy, and also to those who relapsed to
topotecan. A randomized, controlled trial comparing these two
agents in second-line therapy, as well as sacituzumab in the
frontline setting, should be undertaken.”
Dr. David M. Goldenberg, Immunomedics’ founder,
commented that, “Sacituzumab govitecan represents a promising new
therapeutic candidate for advanced mSCLC, a very lethal cancer with
a five-year survival rate of only 6 percent.” Goldenberg continued,
“Importantly, this candidate potentially could be the first new
therapeutic approved for the treatment of metastatic (stage IV)
small-cell lung cancer (mSCLC) in twenty years.”
In the second article published online on May
26, 2017, in the Journal of Clinical Oncology, the authors2
reported the results of the phase II, multicenter trial of 54
heavily-pretreated patients with metastatic NSCLC who received
either 8 or 10 mg/kg sacituzumab govitecan on days 1 and 8 of
21-day cycles. The primary endpoints were safety and objective
response rate (ORR). Progression-free survival (PFS) and overall
survival (OS) were secondary endpoints. Notable findings from the
study include:
- In the response-assessable study population (N = 47), which had
a median of 3 prior therapies (range, 2-7), 67% of patients showed
a shrinkage from baseline CT measurements.
- The confirmed objective response rate was 19.1%, the median
response duration 6.0 months (95% CI, 4.8, 8.3), and the clinical
benefit rate (CR+PR+SD>4 months) was 43%. Responses occurred
with a median onset of 3.8 months, including patients who had
relapsed or progressed after immune checkpoint inhibitor
therapy.
- Median intention-to-treat (ITT) PFS was 5.2 months (95% CI,
3.2, 7.1), and median ITT OS was 9.5 months (95% CI, 5.9,
16.7).
- Grade 3 or higher adverse events included neutropenia (28%),
diarrhea (7%), nausea (7%), fatigue (6%), and febrile neutropenia
(4%).
- Over 90% of 26 assessable archival tumor specimens were highly
positive for Trop-2 by immunohistochemistry.
Dr. D. Ross Camidge, Director of Thoracic
Oncology at the University of Colorado Cancer Center and senior
author of this study, commented, “In a heavily pretreated
population like this, the results with sacituzumab govitecan are
quite encouraging, suggesting further trials both alone and in
combination with other drugs, potentially including immunotherapy,
should be strongly considered.” Camidge continued, “Non-small-cell
lung cancer patients will always benefit from additional
therapeutic choices, and while immunotherapy and oncogene targeted
therapy have certainly revolutionized the treatment for subsets of
the disease, the use of ‘smarter’ chemotherapy in the form of an
effective antibody-drug conjugate such as sacituzumab govitecan may
well be the next major advance we see.”
Dr. Behzad Aghazadeh, Chairman of the Board of
Immunomedics, stated, “These promising results in two lung cancer
indications, comprising the major cancer killers, attest to the
breadth of the therapeutic potential for IMMU-132 in the treatment
of metastatic solid cancers. Our principal focus is to seek
accelerated approval for this ADC in patients with advanced,
heavily-pretreated triple-negative breast cancer (TNBC), for which
there is no approved therapy and significant patient unmet need.”
Aghazadeh continued, “We have also reported that sacituzumab
govitecan, in addition to TNBC, SCLC, and NSCLC, is active in
patients with metastatic urothelial cancers, where we hope to
update results at a future medical meeting, so we now know it is
active in at least four different major solid cancers.”
References1. Gray JE,
Heist RS, Starodub AN, Camidge DR, Kio E, Masters G, Purcell WE,
Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean AJ, Johnson
T, Gandhi L, Kalinsky K, Scheff RJ, Messersmith WA, Govindan SV,
Maliakal P, Mudenda P, Wegener WA, Sharkey RM, Goldenberg DM.
Therapy of small-cell lung cancer (SCLC) with a
topoisomerase-I-inhibiting antibody-drug conjugate (ADC) targeting
Trop-2, sacituzumab govitecan. Clin Cancer Res 2017; epub July 5,
2017.2. Heist RS, Guarino MJ, Masters G, Purcell WT,
Starodub AN, Horn L, Scheff RJ, Bardia A, Messersmith WA, Berlin J,
Ocean AJ, Govindan SV, Maliakal P, Mudenda B, Wegener WA, Sharkey
RM, Goldenberg DM, Camidge DR. Therapy of advanced non-small-cell
lung cancer with an SN-38-anti-Trop-2 drug conjugate, sacituzumab
govitecan. J Clin Oncol 2017; 35 epub May 26, 2017.
About Lung CancerLung cancer is
the most prevalent cancer worldwide; 1.8 million patients were
diagnosed in 2012. It is also the leading cause of cancer deaths,
taking 1.6 million lives annually. The vast majority of lung cancer
cases (85%) comprise the NSCLC type, which has had a median life
expectancy of 10 months when standard chemotherapy is used. With
the introduction of immune checkpoint inhibitors, median survival
has increased to almost 15 months when at least 50% of cells were
positive for PD-L1. In fact, pembrolizumab was reported to be more
effective than chemotherapy in the frontline setting of patients
with metastatic NSCLC at high levels of PD-L1 positivity
(progression-free survival 10.3 months vs. 6.0 months for those
given platinum-based chemotherapy), but this population only
constituted about one-quarter of metastatic NSCLC patients. In
pretreated patients with metastatic NSCLC, the objective response
rates for the immune checkpoint inhibitors generally range from 14%
to 20%.
SCLC comprises approximately 15% of all lung
cancers, and has the worst prognosis. This is because of its highly
aggressive nature, with about two-thirds of patients already having
metastatic disease at diagnosis. While palliative first-line
therapy of stage IV SCLC (mSCLC) has a high initial response rate
of 60% to 75%, the outcome is poor, with a median progression-free
survival of only 5.5 months and a median overall survival of <10
months with platinum-based chemotherapy. Responses to second-line
therapy have been poorer, such as <10%, with a median survival
of only 4 to 5 months following second- or third-line chemotherapy.
Unfortunately, those patients with platinum-resistant mSCLC (i.e.,
response duration <3 months) fare even worse. In the USA, the
only approved drug in this second-line setting of chemosensitive
patients (duration of response exceeding 3 months), since 1998, is
topotecan, indicated for recurrent patients who were sensitive to
frontline chemotherapy with platinum-containing regimens. Still,
irinotecan, taxanes, vinorelbine, gemcitabine, and pemetrexed are
given frequently to patients with chemosensitive recurrent
disease. Even when patients respond to second-line therapies,
there is usually no improved survival. Immune checkpoint inhibitors
have not gained a role in the management of mSCLC.
About Sacituzumab
GovitecanSacituzumab govitecan is a second-generation ADC
composed of a humanized anti-Trop-2 antibody conjugated at a
drug:antibody ratio of 7.6 with SN-38, the active metabolite of the
approved drug, irinotecan. Both irinotecan and SN-38 inhibit the
nuclear enzyme, topoisomerase-1, resulting in double-strand DNA
breaks and death of the affected cells. SN-38 is about 1,000-fold
more potent than its parental prodrug, irinotecan. However, because
it is delivered selectively by the anti-Trop-2 antibody, it is
believed this toxicity is selective for cancer cells having higher
levels of Trop-2 than normal cells. This results in a selective
targeting and killing of cancer cells having Trop-2, which includes
a large number of cancer types. Because of the way SN-38 is
attached to the cancer-targeting antibody, sacituzumab therapy
avoids the debilitating diarrhea caused by irinotecan therapy.
However, like irinotecan, the major adverse effect is neutropenia,
which is manageable either by reducing or delaying therapy, or
treating the patient with a drug that stimulates production of
neutrophils. To-date, sacituzumab govitecan has been studied by
Immunomedics in approximately 500 patients comprising several
different advanced solid cancers.
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer,
autoimmune disorders and other serious diseases. Immunomedics’ most
advanced product candidate is IMMU-132 (sacituzumab govitecan), an
antibody-drug conjugate that has received Breakthrough Therapy
Designation from the FDA for the treatment of patients with
triple-negative breast cancer who have failed at least two prior
therapies for metastatic disease. Immunomedics’ primary goal is to
bring IMMU-132 to market for the benefit of patients and the
creation of shareholder value. For additional information on the
Company, please visit its website at www.immunomedics.com. The
information on its website does not, however, form a part of this
press release.
Cautionary note regarding
forward-looking statementsThis release, in addition to
historical information, may contain forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Such statements, including statements regarding clinical trials
(including the funding therefor, anticipated patient enrollment,
trial outcomes, timing or associated costs), regulatory
applications and related timelines, out-licensing arrangements,
forecasts of future operating results, potential collaborations,
and capital raising activities, timing for bringing any product
candidate to market, involve significant risks and uncertainties
and actual results could differ materially from those expressed or
implied herein. Factors that could cause such differences include,
but are not limited to, the Company’s dependence on business
collaborations or availability of required financing from capital
markets, or other sources on acceptable terms, if at all, in order
to further develop our products and finance our operations, new
product development (including clinical trials outcome and
regulatory requirements/actions), the risk that we or any of our
collaborators may be unable to secure regulatory approval of and
market our drug candidates, risks associated with the outcome of
pending litigation and competitive risks to marketed products, and
the Company’s ability to repay its outstanding indebtedness, if and
when required, as well as the risks discussed in the Company’s
filings with the Securities and Exchange Commission. The
Company is not under any obligation, and the Company expressly
disclaims any obligation, to update or alter any forward-looking
statements, whether as a result of new information, future events
or otherwise.
For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com
Media/Investor Contact:
Dan Zacchei / Jaimee Pavia
Sloane & Company
212-486-9500
Dzacchei@sloanepr.com
Jpavia@sloanepr.com
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