Full Press Release Details
Onconova Therapeutics
Announces Encouraging Clinical Data Supporting the Anti-Cancer Activity of Rigosertib-Nivolumab Combination in Advanced KRAS+ Non-Small
1/2a trial data show an early signal of activity in extensively pre-treated population with 2 partial responses out of 7 evaluable patients
seen in patients with different KRAS mutations
further development of rigosertib, in combination with immune checkpoint inhibitors in KRAS mutated (KRAS+) non-small cell lung cancer
webinar with key opinion leaders to discuss data today at 4:30 p.m. ET
NEWTOWN, Pa., September
22, 2021 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering
and developing novel products for patients with cancer, today announced preliminary safety and efficacy data from an
investigator-initiated Phase 1/2a trial of oral rigosertib plus the immune checkpoint inhibitor nivolumab in advanced KRAS mutated (KRAS+)
non-small cell lung cancer (NSCLC). The data, which are being featured in a presentation at the 3rd Annual RAS Targeted
Drug Development Summit, support the potential anti-cancer activity of rigosertib-nivolumab
combination therapy in this indication and show that the doublet has been well tolerated to-date. Three quarters of patients enrolled
in the trial have failed two or more lines of prior therapy and all have failed immune checkpoint inhibitors in various combinations.
Steven M. Fruchtman,
M.D., President and Chief Executive Officer of Onconova, commented, "The data being presented today support the potential applicability
of rigosertib's mechanism of action against multiple KRAS mutations and its synergy with immuno-oncology therapeutics. Radiographic
responses were seen across multiple KRAS variants, which potentially differentiates rigosertib from other RAS pathway modulators that
target particular KRAS mutations. These responses were observed at the primary tumor site as well as metastatic sites such as the pleura
and bone. These results also suggest that rigosertib may augment the response to checkpoint inhibitors, which is consistent with observations
from preclinical studies, with potential applicability to indications such as NSCLC, melanoma, and others. Looking forward, we will continue
to leverage our investigator-initiated study program to advance rigosertib's clinical development in high-need KRAS mutated indications
while keeping our primary focus on our lead ON 123300 (narazaciclib) program."
data from the presentation include:
rigosertib with the immune checkpoint inhibitor nivolumab has been well tolerated and notably led to partial responses in 29% of evaluable
patients who had previously progressed on prior checkpoint inhibitor therapies," said Rajwanth Veluswamy, M.D., Assistant Professor,
Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai and Principal Investigator of the trial. "This
safety and early efficacy signal highlights the combination of rigosertib and nivolumab's ability to target KRAS mutated NSCLCs
and potentially overcome immune checkpoint inhibitor resistance mechanisms. Importantly, responses were seen with different KRAS+ variants,
addressing a critical unmet need."
M.D., Chief Medical Officer of Onconova, commented, "We look forward to the continuation of this study and to continue development
of the rigosertib nivolumab combination as a potential treatment for patients with limited therapeutic options."
presentation titled, "Phase 1/2 Trial of Rigosertib & Nivolumab in KRAS-Mutated NSCLC in 2nd+ Line" will be
available on the "Scientific Presentations" section of the Onconova website following the conference.
Expert Overview from Key Opinion Leaders
a webinar today, September 22, 2021, at 4:30 p.m. ET to discuss the preliminary Phase 1/2a data. The call will feature expert discussion
with Dr. Veluswamy and Scott Antonia, M.D., Ph.D., Professor of Medicine at the Duke Cancer
Institute and Director of its Center for Cancer Immunotherapy. A question and answer session with these experts will follow formal presentations
by Dr. Veluswamy and members of the Onconova management team.
attend the webinar, click here. A replay of the webinar will be available by visiting the investors and media page on Onconova's
website at www.onconova.com and clicking on the webcast link.
Investigator-initiated Phase 1/2a Trial
trial is designed to evaluate the combination of rigosertib and nivolumab in advanced KRAS+ metastatic NSCLC patients who have progressed
on standard of care with anti-PD-1 monotherapy or anti-PD-1 in combination with chemotherapy. It includes a dose-escalating Phase 1 portion
followed by a Phase 2a dose-expansion portion. Patients in the trial receive oral rigosertib twice daily on days 1-21, and intravenous
nivolumab on days 1 and 15 of 28-day cycles. The primary endpoints of the trial are safety assessments to determine maximum tolerated
dose and overall response rate. Secondary endpoints include progression free survival and overall survival. For more information on the
trial, see ClinicalTrials.gov Identifier: NCT04263090.
Onconova Therapeutics
is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company
has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and
expansion studies. These trials are currently underway in the United States and China.
product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion
Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung
For more information,
please visit www.onconova.com.
Some of the statements
in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E
of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties.
These statements relate to Onconova's expectations regarding the timing of Onconova's and investigator-initiated clinical
development and data presentation plans, and the mechanisms and indications for Onconova's product candidates. Onconova has attempted
to identify forward-looking statements by terminology including "believes," "estimates," "anticipates,"
"expects," "plans," "intends," "may," "could," "might," "will,"
"should," "preliminary," "encouraging," "approximately" or other words that convey uncertainty
of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable
as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking
statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the
success and timing of Onconova's clinical trials, investigator-initiated trials and regulatory agency and institutional review board
approvals of protocols, Onconova's collaborations, market conditions and those discussed under the heading "Risk Factors"
in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in
this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this
release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.