Aileron Therapeutics (NASDAQ: ALRN), the clinical-stage leader in the field of stabilized, cell-permeating peptides to treat cancer patients, announced the presentation of interim results from its ongoing Phase 2a clinical trial evaluating the combination of ALRN-6924 and Pfizer’s IBRANCE® (palbociclib) for the treatment of patients with tumors harboring wild-type p53 and MDM2 amplification or MDM2/CDK4 co-amplification at the 2019 Congress of the European Society for Medical Oncology (ESMO) (Presentation Number: 475P).
As of the data cutoff date of September 2, 2019, the trial had enrolled 26 patients. “We are pleased with the strong interest from our investigators, which led to significant acceleration in the rate of enrollment in the trial,” stated Dr. Vojislav Vukovic, Chief Medical Officer of Aileron. “The vast majority of patients enrolled thus far are sarcoma patients, including 20 with liposarcoma, as MDM2 amplification or MDM2/CDK4 co-amplification is very often found in this tumor type.”
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.
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