Aileron Presents Positive Interim Phase 2a Data for ALRN-6924 in Combination with Pfizer’s Palbociclib at the 2019 Congress of the European Society for Medical Oncology
As of the data cutoff date of
The reported safety results show that the combination has been very well-tolerated in the trial, with the most common non-hematological related adverse events grade ≤2 being nausea (46%) and fatigue (23%). Neutropenia was the only grade ≥3 hematological related AE occurring in >5% of patients (27%), while grade ≥3 thrombocytopenia and leukopenia each were observed in only one patient (3.8%).
The preliminary analysis of activity in the 17 evaluable patients with liposarcoma showed a disease control rate of 88% and a median progression-free survival of 4.4 months with 53% censoring. No partial or complete responses have been observed. Patients who have had at least one post-baseline assessment and have MDM2-amplified, TP53-WT tumors were deemed evaluable.
On the basis of these encouraging preliminary safety and efficacy results, the Company expects that the first indication for the combination of ALRN-6924 and palbociclib may be MDM2-amplified sarcoma patients, for whom there exists a substantial unmet need across all lines of treatment for the estimated 15,000 patients worldwide diagnosed each year. In addition, these results have further encouraged the Company to expand enrollment to a total of 35 patients in order to evaluate the combination on the treatment of other MDM2-amplified cancers. Aileron expects to announce a final data readout in the second quarter of 2020.
The Aileron poster containing the trial results can be accessed via the following link:
ALRN-6924, is a first-in-class dual MDM2/MDMX inhibitor that is currently being evaluated in a Phase 2a clinical trial in combination with Pfizer’s palbociclib (Ibrance®) for the treatment of MDM2-amplified advanced solid tumors, and is planned to be evaluated in an upcoming Phase 1b/2 clinical trial to evaluate ALRN-6924 as a myelopreservative agent to protect against chemotherapy-induced toxicities.
For information about Aileron’s clinical trials, please visit www.clinicaltrials.gov.
Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides that address the most important intracellular targets in oncology and other therapeutic areas. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in drug candidates like ALRN-6924. Our current focus is to improve the standard of care for patients with cancer by developing safe and effective therapies and cancer supportive care treatments that leverage our proprietary peptide platform. For more information, visit www.aileronrx.com, and for more information about our clinical trials please visit www.clinicaltrials.gov.
Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company’s strategy and clinical development plans. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether Aileron’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the
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Source: Aileron Therapeutics, Inc.