Exhibit 99.1
ORIC Pharmaceuticals Reports Initial Clinical Data Being Presented at ASCO from Phase 1b Trial of ORIC-101 in Combination with Nab-Paclitaxel
June 2, 2021
Initial safety data showed combination regimen at the recommended Phase 2 dose was well tolerated; treatment-related adverse events primarily Grade 1 or 2, with no treatment-related discontinuations
ORIC-101 plasma concentrations provided excellent target coverage; no evidence of drug-drug interaction with nab-paclitaxel
Translational data showed pharmacodynamic modulation of GR biomarkers and high rates of GR expression in tumor types of interest
Antitumor activity demonstrated across multiple advanced solid tumors in heavily pretreated patients, including those previously treated with a taxane-based therapy
Extended PFS observed in patients with late-line relapsed pancreatic cancer who had previously progressed on or after nab-paclitaxel
Conference call and webcast today at 5:00 p.m. ET
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) — ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced initial data from an ongoing Phase 1b study evaluating ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel, in advanced solid tumors. The data will also be presented in two posters at the American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4 – 8, 2021.
“We are excited to share initial data from our ORIC-101 clinical program in patients with advanced solid tumors. We are pleased that the combination was well tolerated without evidence of drug-drug interaction and has demonstrated both tumor regression and prolonged stable disease in multiple heavily pretreated tumors,” said Pratik S. Multani, MD, chief medical officer. “Although early, we are particularly intrigued by the potential benefit seen in patients with late-line relapsed pancreatic cancer previously treated with nab-paclitaxel, as any retreatment benefit in such patients would not be expected. We are continuing to enroll patients in the expansion cohorts and look forward to reporting updated data from the Phase 1b trial in 2022.”
“Having been involved with this study from its design stage, I feel we have developed an optimal combination for this heavily pretreated patient population,” said Professor Pamela Munster, MD, Director of the University of California San Francisco’s Early Phase Clinical Trials Unit, and trial investigator and senior author of the ASCO poster. “I’m impressed by the extended time on treatment we’ve seen in patients with late-line pancreatic cancer; seeing clinical activity in these patients is quite remarkable.”
Trial Design and Initial Results from Phase 1b Clinical Trial
The Phase 1b clinical trial of ORIC-101 in combination with nab-paclitaxel is a single arm, multicenter, open-label study conducted in two parts, intended to establish the recommended Phase 2 dose (RP2D), safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity when administered to patients with advanced or metastatic solid tumors.
In the Part I dose escalation portion of the study, five cohorts of patients across multiple solid tumors were enrolled to evaluate ORIC-101 doses ranging from 80 to 240 mg administered orally in both intermittent and continuous once daily dosing regimens, in combination with either 75 or 100 mg/m2 nab-paclitaxel. Following the completion of the dose escalation portion of the study, the RP2D was determined to be 160 mg of ORIC-101 continuous once daily dosing and 75 mg/m2 of nab-paclitaxel on days 1, 8, and 15 of a 28-day cycle, without requirement for prophylactic granulocyte-colony stimulating factor (G-CSF).
For the Part II dose expansion portion of the study, up to 132 patients are expected to be enrolled across four cohorts, including pancreatic ductal adenocarcinoma (PDAC), ovarian cancer, triple negative breast cancer, and other advanced solid tumors. Enrollment continues in the Part II dose expansion cohorts at 12 clinical sites across the United States. Patients in the dose expansion portion of the study are required to have previously progressed on a taxane-based therapy, with retrospective analysis of GR expression and other potentially predictive biomarkers.
Safety Analyses:
| | • | | As of March 31, 2021, a total of 31 patients were enrolled across Parts I/II of the study, which included 12 patients treated at non-RP2D doses and 19 patients treated at the RP2D of 160 mg of ORIC-101 continuous once daily dosing and 75 mg/m2 of nab-paclitaxel. |
| | • | | Patients treated at the RP2D were heavily pretreated, with a median of four prior therapies, and all had previously received a taxane-based therapy. |
| | • | | As of the database cutoff date of April 21, 2021, the RP2D was well tolerated; treatment-related adverse events were primarily Grade 1 or 2, with only three Grade 3 events, which all resolved with dose interruption. |
| | • | | There were no treatment-related discontinuations and no requirement for prophylactic G-CSF at the RP2D. |
Preliminary Antitumor Activity (as of the database cutoff date of April 21, 2021):
| | • | | The efficacy evaluable population included a total of 23 patients who had an opportunity for at least one on-treatment tumor assessment. |
