Docetaxel

Initiated Himalayas-1 global Phase 3 trial in patients with mCRPC previously treated with abiraterone Entered into a clinical trial collaboration and supply agreement with Bayer to provide darolutamide for Himalayas-1 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, July 14, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the initiation of the Himalayas-1 global Phase 3 registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone and announced a clinical trial collaboration and supply agreement with Bayer AG (“Bayer”). Himalayas-1 Global Phase 3 Registrational Trial Initiation ORIC previously presented dose optimization data for rinzimetostat in combination with darolutamide and selected 400 mg once daily rinzimetostat as the recommended Phase 3 dose (RP3D). Following End-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the trial protocol and has initiated the Himalayas-1 global Phase 3 registrational trial. The Himalayas-1 trial is expected to enroll approximately 600 patients from over 250 sites in 25 countries, randomized 1:1 to receive the RP3D of 400 mg once daily rinzimetostat (with or without food) in combination with darolutamide versus physician’s choice of an androgen receptor (AR) inhibitor or docetaxel. The primary endpoint is radiographic progression-free survival, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes. Clinical Trial Collaboration and Supply Agreement with Bayer Under the terms of the agreement, ORIC will conduct and sponsor the Himalayas-1 trial and Bayer will provide their AR inhibitor, NUBEQA® (darolutamide), at no cost for use in the trial in combination with rinzimetostat. This agreement does not grant Bayer any license, option, or other rights to rinzimetostat and ORIC retains full global development and commercial rights to rinzimetostat. “Given the significant unmet need in prostate cancer and the potential best-in-disease clinical profile that rinzimetostat has continued to demonstrate, the initiation of our Himalayas-1 Phase 3 trial represents an important milestone toward establishing rinzimetostat as a potentially practice-changing therapy for patients,” said Jacob M. Chacko, M.D., president and chief executive officer. “This collaboration with Bayer strengthens our global operational readiness by securing access to darolutamide for Himalayas-1 and underscores our shared interest in evaluating this regimen for patients with prostate cancer.” About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, being developed for NSCLC. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, expectations and plans regarding the Himalayas-1 global Phase 3 registrational trial in mCRPC evaluating rinzimetostat in combination with NUBEQA® (darolutamide); the continued clinical development of rinzimetostat; the potential advantages of rinzimetostat; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-disease profile of rinzimetostat; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and ORIC’s limited operating history; ORIC’s ability to complete clinical trials for, obtain approvals for and commercialize rinzimetostat; delays or difficulties in the enrollment and/or maintenance of patients in the Himalayas-1 clinical trial; changes in ORIC’s plans to develop and commercialize rinzimetostat; the potential for clinical trials of rinzimetostat to differ from preclinical, initial, interim, preliminary, expected or prior clinical trial results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements, including its agreement with Bayer; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 4, 2026, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com

CSPC Pharmaceutical Group Limited (HKEX: 01093) announced that China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation to both docetaxel for injection (albumin-bound) (HB1801) and anbenitamab (KN026), a HER2-targeted bispecific antibody, for use in combination as first-line treatment of unresectable or metastatic HER2-positive breast cancer in adults. The designation accelerates regulatory review and provides more intensive NMPA guidance during development — and arrives five weeks after the Phase III Healer trial (KN026-003) reported that the combination met its primary endpoint of progression-free survival (PFS) against the current standard of care. Anbenitamab simultaneously binds two non-overlapping epitopes on the HER2 receptor, enabling dual-domain signal blockade through a single molecule. This mechanism is mechanistically distinct from the two-antibody approach of the trastuzumab-pertuzumab combination used in the standard THP regimen (trastuzumab plus pertuzumab plus docetaxel). Through antibody-induced receptor clustering, anbenitamab also enhances antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity while promoting HER2 receptor downregulation. HB1801 encapsulates docetaxel in human serum albumin, eliminating the polysorbate 80 and ethanol solvents required by conventional docetaxel formulations, removing the need for steroid premedication and permitting higher-concentration administration. The Healer trial (KN026-003) is a randomized, controlled, open-label, multicenter Phase III study designed to enroll approximately 880 patients with HER2-positive advanced breast cancer, assigned 1:1 to anbenitamab plus HB1801 or the THP regimen. The primary endpoint is PFS as assessed by a Blinded Independent Review Committee (BIRC). In June 2026, the Independent Data Monitoring Committee determined that the combination statistically significantly prolonged PFS and reduced the risk of disease progression or death compared with THP, with a trend toward an overall survival benefit. No specific hazard ratio, median PFS figures, or p-values have been disclosed; detailed data are expected at an upcoming international academic conference. The neoadjuvant Phase III trial (Neo-Healer, KN026-004) has provided the most granular publicly available efficacy data for this combination. Presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology Annual Meeting, the trial enrolled 521 patients with early or locally advanced HER2-positive breast cancer and randomized them 1:1 to anbenitamab plus HB1801 ± carboplatin or THP ± carboplatin for six cycles. The BIRC-assessed total pathological complete response (tpCR) rate was 62.4% (95% CI: 56.2–68.2) in the experimental arm versus 51.2% (95% CI: 44.9–57.4) in the control arm (one-sided p \= 0.0036). The Breakthrough Therapy Designation for the first-line advanced setting directly supports the companies’ stated plan to submit a New Drug Application (NDA) to the NMPA for this indication in the near future. Under China’s Breakthrough Therapy pathway, designated products receive priority scheduling, more frequent interactions with the NMPA’s Center for Drug Evaluation, and eligibility for rolling review. Anbenitamab had previously received NMPA Breakthrough Therapy Designation for HER2-positive advanced gastric cancer following failure of first-line treatment, and that program culminated in marketing authorization granted in May 2026. CSPC and its co-development partner, China-based Alphamab Oncology (HKEX: 09966), have positioned the HB1801 plus anbenitamab combination across the full HER2-positive breast cancer disease continuum. Phase III trials now cover neoadjuvant (Neo-Healer, primary endpoint met), adjuvant (ongoing), and first-line advanced (Healer, primary endpoint met) settings, with the Breakthrough Therapy Designation applying to the advanced first-line indication. The NDA submission for the neoadjuvant breast cancer indication is also described as forthcoming. Anbenitamab holds only an FDA Orphan Drug Designation for HER2-positive gastric cancer and has not entered US registration-enabling trials for breast cancer. The next material milestone is the public presentation of full Healer (KN026-003) efficacy and safety data, including the PFS hazard ratio, median PFS, and subgroup analyses, at an international academic conference. That dataset will determine whether the magnitude of PFS benefit over THP supports the regulatory and commercial case for the combination in first-line advanced HER2-positive breast cancer, and will inform the scope and timing of the planned NDA submission to the NMPA. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.