Arrowhead Presents New Clinical Data on ARO-HIF2 at ASCO GU 2022
Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced positive interim results from the Phase 1b AROHIF21001 trial for ARO-HIF2, targeting clear cell renal cell carcinoma (ccRCC). The study showed a significant reduction in HIF2α expression, with 9 out of 14 patients demonstrating decreased protein levels. In terms of safety, ARO-HIF2 was well-tolerated, with 12% of patients reporting anemia and hypoxia. The data, presented at the 2022 ASCO GU symposium, highlighted a 39% disease control rate across all cohorts, underscoring the potential of ARO-HIF2 as a therapeutic option in ccRCC.
- Phase 1b AROHIF21001 trial results showed target engagement with reductions in HIF2α expression.
- 9/14 patients exhibited reductions in HIF2α protein levels.
- 39% disease control rate across all cohorts, indicating potential efficacy.
- ARO-HIF2 was well-tolerated, with manageable safety profile.
- 12% of patients reported anemia and hypoxia as adverse events.
- Five serious adverse events reported possibly related to the treatment.
Presentation Details:
Title: Initial results from the phase 1 study of ARO-HIF2 to silence HIF2-alpha in patients with advanced ccRCC (AROHIF21001)
Authors:
Session: Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers
Abstract Number: 339
Poster Number: F9
Key results from AROHIF21001 as of
Pharmacodynamics and Efficacy
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Tumoral expression of HIF2α protein was assessed via immunohistochemistry
- Among patients with evaluable biopsy, 9/14 showed reductions in HIF2α protein
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Responders in Cohort 1 (225 mg, n=3), Cohort 2 (525 mg, n=4), and Cohort 3 (1050 mg, n=2) achieved mean reductions of HIF2α protein of -
45% , -57% , and -80% , respectively
-
Tumoral expression of HIF2α messenger RNA (mRNA) was assessed by quantitative polymerase chain reaction (qPCR)
- Among patients with evaluable biopsy, 9/9 showed reductions in HIF2α mRNA
-
Cohort 1, Cohort 2, and Cohort 3 achieved mean reductions of HIF2α mRNA of -
38% , -28% , and -44% , respectively
-
Efficacy was assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
-
Disease control rate (complete response + partial response + stable disease) was
39% (10 of 26) across all cohorts -
Objective response (complete response + partial response) was
8% (2 of 26), with one patient in Cohort 2 and one patient in Cohort 3 achieving a partial response
-
Disease control rate (complete response + partial response + stable disease) was
Safety
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ARO-HIF2 was generally well-tolerated in patients. Anemia and hypoxia, frequently reported on-target adverse events (AEs) with small molecule HIF2α inhibitors, were reported in
12% of patients - Five serious AEs in 5 patients were reported by investigators as possibly drug related, including myocarditis (in a patient with a history of TKI induced cardiomyopathy), demyelinating neuropathy (in a patient with autoimmune sequelae due to checkpoint inhibitors), chronic inflammatory demyelinating polyradiculoneuropathy (in a patient with distant history of checkpoint inhibitor use), hypoxia (in a patient with a pulmonary infiltrate), and acute hypoxemic respiratory failure (in a patient with progressive lung metastatic disease)
A copy of the presentation materials with full data may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.
AROHIF21001 (NCT04169711) is a Phase 1b dose-finding clinical study in patients with advanced ccRCC to evaluate the safety of ARO-HIF2 and to determine the recommended Phase 2 dose. Secondary objectives include the assessment of pharmacokinetics and preliminary efficacy, based on Response Evaluation Criteria in Solid Tumors (RECIST). Exploratory objectives for AROHIF21001 are post-dose tumoral expression of HIF genes in response to treatment with ARO-HIF2, change in Karnofsky Performance Status (KPS), correlation of tumor response based on RECIST with tumor HIF2α gene expression and tumor integrin expression, correlation of integrin expression with changes in HIF gene expression, evaluation of serum biomarkers of ARO-HIF2 activity, correlation of RCC-related gene expression to ARO-HIF2 activity, and evaluation of plasma and urine metabolites.
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