Rigel Announces Collaboration with CONNECT to Conduct a Phase 2 Trial of Olutasidenib in Glioma
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Insights
The collaboration between Rigel Pharmaceuticals and CONNECT to conduct a Phase 2 clinical trial for REZLIDHIA in pediatric and young adult patients with high-grade glioma is a significant step in oncology therapeutics. The focus on IDH1 mutation-positive HGG, particularly in rare and aggressive forms like diffuse intrinsic pontine glioma, addresses a critical gap in current treatment options. The trial's design, which includes a combination therapy followed by maintenance treatment, reflects a strategic approach to potentially improve progression-free survival, a key outcome for oncology trials.
Given the orphan drug status often associated with pediatric cancers, the development of treatments like olutasidenib could lead to substantial market exclusivity and pricing power if successful. The financial commitment of up to $3 million by Rigel Pharmaceuticals underscores the potential they see in olutasidenib's efficacy across various cancer types. This trial could set a precedent for future pediatric oncology treatments and pave the way for Rigel's expansion within the hematology-oncology pipeline.
The strategic collaboration between Rigel Pharmaceuticals and CONNECT holds potential financial implications for Rigel's business model and stock performance. The upfront investment of $3 million, while modest relative to the overall R&D budgets of pharmaceutical companies, indicates Rigel's confidence in olutasidenib's market potential. The pediatric oncology market is notably underserved and successful trial outcomes can lead to expedited regulatory processes and market entry.
Investors should monitor the enrollment progress and interim results of the trial, as positive data could lead to stock price appreciation. However, the inherent risks of clinical trials, especially in the challenging field of pediatric oncology, should be considered. Delays, adverse safety profiles, or efficacy concerns could negatively impact Rigel's financial standing and investor sentiment.
REZLIDHIA's trial in pediatric and young adult HGG patients is a medically important endeavor. High-grade gliomas are notoriously difficult to treat and the prognosis for patients, especially with DIPG, remains poor. The choice of combination therapy with temozolomide, a standard chemotherapeutic agent, suggests a synergistic approach to target tumor cells more effectively. The maintenance phase with olutasidenib monotherapy could potentially manage the disease over a longer period.
Understanding the pharmacokinetics of olutasidenib in younger patients is crucial, as their metabolic profiles differ from adults. This trial not only aims to extend survival but also to maintain a quality of life, which is paramount in pediatric care. The trial's success could revolutionize the treatment landscape for pediatric HGG and offer hope to patients and families facing this devastating diagnosis.
Under the collaboration, CONNECT will include olutasidenib in CONNECT's TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients (less than 39 years old) with IDH1 mutation positive HGG, including diffuse intrinsic pontine glioma (DIPG), an aggressive brain tumor with limited treatment options. Rigel will provide funding up to
"We are excited to collaborate with CONNECT to evaluate olutasidenib in high grade glioma," said Raul Rodriguez, Rigel's president and CEO. "We believe olutasidenib has potential in a variety of cancers where mIDH1 plays an important role and we look forward to generating new data in this disease state, which has a high unmet need. This collaboration builds on our hematology-oncology pipeline expansion strategy and enables us to explore the potential of olutasidenib in a focused and efficient manner."
This open label Phase 2 trial will be overseen by Drs. Santosh Valvi and Nicholas Gottardo, Perth Children's Hospital, Dr. Michael J Fisher, Children's Hospital of
In January 2023, data was published in the peer-reviewed journal Neuro-Oncology from a multicenter, open label, Phase 1b/2 trial of 26 patients with R/R and predominantly enhancing gliomas harboring an IDH1 mutation. The data showed that olutasidenib 150 mg BID was well tolerated and demonstrated preliminary evidence of clinical activity and prolonged disease control in this heavily pretreated population. The authors noted that olutasidenib is a potent, brain-penetrant, selective inhibitor of mutant IDH1.1 The paper, titled "Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial" can be accessed here.
REZLIDHIA is FDA-approved for the treatment of adult patients with R/R acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
About REZLIDHIA®
INDICATION
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION SYNDROME |
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in
If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.
Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in
Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.
ADVERSE REACTIONS
The most common (≥
DRUG INTERACTIONS
- Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
- Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.
GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.
HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.
Click here for Full Prescribing Information, including Boxed WARNING.
To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
REZLIDHIA is a registered trademark of Rigel Pharmaceuticals, Inc.
About Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in
About CONNECT
CONNECT is an international collaborative network of pediatric cancer centers with the objective to improve outcomes for children with brain tumors. CONNECT conducts small, scientifically rational, pilot and early phase studies to assess feasibility and early efficacy of incorporating promising new therapies into established frontline therapeutic regimens. For more information on CONNECT, visit connectconsortium.org.
- de la Fuente M, et al. Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: A multicenter, open-label, phase Ib/II trial. Neuro Oncol. 2023 Jan 5;25(1):146-156. doi: 10.1093/neuonc/noac139.
Forward Looking Statements
This press release contains forward-looking statements relating to, among other things, that olutasidenib may provide a meaningful approach to the treatment of patients with glioma, the enrollment of patients in the Phase 2 study of olutasidenib, and the use of the safety and efficacy data from the Phase 2 study of olutasidenib in glioma. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "aims", "expected", "explore" "potential", "look forward", "believe", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigel's product candidates; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law.
Investors & Media Contacts:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David Rosen
Argot Partners
Phone: 212.600.1902
Email: david.rosen@argotpartners.com
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SOURCE Rigel Pharmaceuticals, Inc.
FAQ
What is the collaboration announced by Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL)?
What is the primary objective of the olutasidenib arm of the trial?
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What is the FDA approval status of REZLIDHIA?
What data was published in January 2023 related to olutasidenib?
