OncoMed Announces Interim Phase 1b Results for Navicixizumab and Paclitaxel Combination Therapy in Platinum-resistant Ovarian...
October 22 2018 - 8:00AM
Overall Clinical Benefit Rate of 85%,
Partial Response Rate of 42% and Progression Free Survival of 5.4
Months Observed in Patients with > 2 Prior Therapies and/or
Prior Bevacizumab
OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage
biopharmaceutical company focused on discovering and developing
novel anti-cancer therapeutics, today announced interim results
from its ongoing Phase 1b trial investigating navicixizumab,
OncoMed’s anti-DLL4/VEGF bispecific antibody, in combination with
paclitaxel in patients with platinum-resistant ovarian cancer.
The interim results were presented at the European Society for
Medical Oncology in Munich. The patients had received a median of
four prior therapies, all of whom had received prior paclitaxel and
69% had received prior bevacizumab. Twenty-two of the 26 patients
(85%) treated with the novel regimen experienced clinical benefit.
Notably 11 of the 26 patients (42%) achieved a partial response and
the median progression-free survival was 5.4 months (95% CI:
3.5-8.0 months). Historical response rates for patients with
heavily pretreated platinum-resistant ovarian cancer treated with
chemotherapy are typically 15% or less.
“These are impressive results that warrant further evaluation in
this historically difficult-to-treat patient population,” said
Kathleen Moore, M.D., Jim and Christy Everest Endowed Chair in
Cancer Research, Clinical Research Director, University of Oklahoma
Health Science Center and one of the lead investigators for the
Phase 1b clinical trial. “When ovarian cancer stops responding to
platinum-based therapy, our best option is chemotherapy plus
bevacizumab, which may be effective, but often for only a short
duration. Following this line of therapy, there are no approved,
effective options for patients. Combination weekly paclitaxel and
navicixizumab appears to provide durable responses among patients
with multiple lines of prior therapy and/or prior exposure to
bevacizumab, which represents a high unmet need.”
The ongoing Phase 1b multicenter, open-label, dose-escalation
and expansion trial is designed to assess the safety, preliminary
efficacy, immunogenicity, pharmacokinetics and biomarker effects of
navicixizumab plus paclitaxel. The trial has been expanded to
enroll up to 60 patients with platinum-resistant ovarian cancer
(including fallopian tube or primary peritoneal cancers) who have
previously received bevacizumab and/or have failed at least two
prior therapies.
Additional highlights from the poster were:
- The median number of prior therapies was four. All patients had
previously received paclitaxel and 69% had received
bevacizumab.
- The RECIST response rate was 42% and the RECIST response rate
in the bevacizumab naïve and bevacizumab pretreated patients was
57% and 33%, respectively.
- CA-125 is a widely utilized tumor marker for ovarian cancer
that is used along with radiographic assessments to determine the
efficacy outcome to treatment. Of the 23 patients evaluable for a
GCIG CA-125, 14 (61%) had a response. Specifically, the CA-125
response rates in the bevacizumab naïve and bevacizumab pretreated
patients were 100% and 47%, respectively.
- The overall median progression free survival (PFS) was 5.4
months (95% CI: 3.5 – 8 months). The median PFS for the subset of
bevacizumab pretreated patients was 3.7 months (95% CI: 3.3 months
– not reached).
- The most common related adverse events of any grade related to
navicixizumab were hypertension (53%), fatigue (32%), diarrhea
(24%) and headache (18%). Other related rare adverse events of
special interest were one Grade 2 pulmonary hypertension, one Grade
1 related heart failure, one Grade 4 related gastrointestinal
perforation and one Grade 4 thrombocytopenia. Three patients (12%)
experienced infusion reactions that were associated with anti-drug
antibodies which impacted drug exposure.
About Navicixizumab OncoMed's anti-DLL4/VEGF
bispecific antibody, navicixizumab, is designed to inhibit the
function of both DLL4 and VEGF and thereby induce potent anti-tumor
responses while mitigating certain angiogenic-related toxicities.
Navicixizumab was developed utilizing OncoMed's BiMAb™ bispecific
platform technology, which enables the design of bispecific
antibodies comparable to traditional monoclonal antibodies but
possessing dual target-binding specificity. In preclinical studies,
navicixizumab demonstrated robust in vivo anti-tumor efficacy
across a range of solid tumor xenografts, including colon, ovarian,
lung and pancreatic cancers, among others. Further, in preclinical
studies dual inhibition of DLL4 and VEGF appeared to exhibit
synergistic anti-tumor activity at doses where blockade of either
target alone elicited sub-optimal activity. In a Phase 1a study
with single-agent navicixizumab published in Investigational New
Drugs, 19 of 66 patients with various types of refractory solid
tumors had tumor shrinkage following treatment with navicixizumab.
Notably, 3 of the 12 (25%) ovarian cancer patients treated in the
trial achieved a partial response with single-agent navicixizumab
therapy.
About OncoMed Pharmaceuticals OncoMed
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on discovering and developing novel anti-cancer
therapeutics. OncoMed has internally discovered a broad pipeline of
investigational drugs intended to address the fundamental biology
driving cancer's growth, resistance, recurrence and metastasis.
Product candidates in OncoMed’s portfolio include navicixizumab
(anti-DLL4/VEGF bispecific, OMP-305B83), etigilimab (anti-TIGIT,
OMP-313M32), and GITRL-Fc (OMP-336B11). OncoMed also continues to
pursue new drug discovery research. For further information about
OncoMed Pharmaceuticals, please see www.oncomed.com.
Forward Looking Statements To the extent that
statements contained in this press release are not descriptions of
historical facts regarding OncoMed Pharmaceuticals, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including, without limitation, OncoMed's intentions and
expectations regarding the potential of navicixizumab as a
treatment for ovarian cancer patients previously treated with
multiple lines of therapy and/or with bevacizumab, and the
durability of responses to navicixizumab in such patients; and the
ability of navicixizumab to induce potent anti-tumor responses
while mitigating angiogenic-related toxicities. Such
forward-looking statements involve substantial risks and
uncertainties that could cause OncoMed's clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the preclinical and
clinical development process; OncoMed's ability to raise additional
capital to support the development of its unpartnered programs; and
OncoMed's dependence on its key executives. OncoMed undertakes no
obligation to update or revise any forward-looking statements. For
a further description of the risks and uncertainties that could
cause actual results to differ from those expressed in these
forward-looking statements, as well as risks relating to OncoMed's
business in general, see OncoMed's Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) on March 9,
2018, OncoMed’s Quarterly Report on Form 10-Q filed with the SEC on
August 2, 2018, and OncoMed's other current and periodic reports
filed with the SEC.
Contacts Sylvia Wheeler
sylvia.wheeler@oncomed.com |
Alexandra Santos asantos@wheelhouselsa.com |
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