Latest news with #ARPI
Business Wire
3 days ago
- Business
- Business Wire
The ArteraAI Prostate Test Enhanced with New Insights for Higher Risk Patients with Localized Prostate Cancer
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, has updated its award-winning ArteraAI Prostate Test with new insights to help higher-risk patients optimize treatment decisions. Artera recently presented its validation data at the 2025 ASCO Annual Meeting, demonstrating the test's ability to identify high-risk, non-metastatic prostate cancer patients most likely to benefit from the addition of abiraterone to standard therapy from those who don't. The STAMPEDE trial helped to establish abiraterone, an androgen receptor pathway inhibitor (ARPI), along with radiation and long-term androgen deprivation therapy (LT-ADT) as the standard of care treatment for high-risk patients, but clinicians and patients have been hesitant with its usage due to concerns around side effects, complex follow-up care, and added cost. Artera's MMAI model was used to analyze the STAMPEDE trial patient cohort and identified that only 25% of high-risk non-metastatic patients derived meaningful benefit from abiraterone intensification, suggesting the opportunity to spare up to 75% of this cohort from unnecessary toxicities. The commercially available ArteraAI Prostate Test provides personalized prognostic and predictive test results to guide treatment decisions. For lower-risk patients, the test can help determine if active surveillance is a suitable option, and for intermediate-risk patients, the test can predict if short-term androgen deprivation therapy (ST-ADT) is beneficial. With this new product enhancement, the ArteraAI Prostate Test will increase its clinical impact for higher-risk patients. 'We are very excited to improve the clinical utility of our test in order to better serve a patient population faced with difficult choices to make about their cancer care,' said Timothy Showalter, Chief Medical Officer of Artera. 'It's a real testament to the team here at Artera, from clinical development to engineering and beyond, that we're able to quickly take insights from the clinical research realm, rigorously validate it and to deploy it so quickly to help patients.' Prostate cancer is one of the most common cancers, with over 300,000 new diagnoses each year. While high-risk disease only constitutes ~15% of cases, 10-year survival rate is poor at only 65%. Because of the cancer's aggressiveness, clinicians will often deploy multiple therapeutic agents at the same time, but this increases drug toxicities and can be costly. The appeal of precision medicine is to be able to determine which therapies will be beneficial and avoid under- or over-treatment. 'Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,' said Nick James, MD, PhD, lead investigator of the STAMPEDE trial. 'We know that for many men with cancer that has not yet spread, it can also have spectacular results. We're excited to now have a test that can pick out the people who will respond best to abiraterone, and those who will do well from standard treatment alone – hormone therapy and radiotherapy.' About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
30-05-2025
- Health
- Business Wire
(radium-223 dichloride) Data in Metastatic Castration-Resistant Prostate Cancer from Phase III PEACE III Trial Published in
WHIPPANY, N.J.--(BUSINESS WIRE)-- Annals of Oncology published full results from the pivotal investigational Phase III PEACE III trial, evaluating XOFIGO ® (radium-223 dichloride) in combination with enzalutamide, an AR pathway inhibitor (ARPI), versus enzalutamide alone in the first-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. 1 XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. 2 Initially presented as a late-breaking abstract during the Presidential Symposium at ESMO 2024, results demonstrated that the addition of XOFIGO to enzalutamide significantly increased radiological progression-free survival (rPFS) for patients with mCRPC with bone metastases, with a 31% reduction in the risk of progression or death (HR 0.69; 95% CI, 0.54-0.87; p=0.0009) compared to enzalutamide alone. 1,3 Patients receiving XOFIGO in combination with enzalutamide had a median rPFS of 19.4 months (95% CI, 17.1-25.3 months) compared to 16.4 months (95% CI, 13.8-19.2 months) with enzalutamide, a 3-month difference in median rPFS. 1,3 The trial was a collaboration between the European Organization for Research and Treatment of Cancer (EORTC), Clinical Trial Ireland (CTI), the Canadian Urological Oncology Group (CUOG), the Latin American Cooperative Oncology Group (LACOG), and French UNICANCER Urogenital Tumor Study Group (GETUG). Additionally, at a preplanned interim analysis the results demonstrated statistically significant overall survival (OS), with a 31% reduction in the risk of death (HR=0.69; 95% CI 0.52-0.90; p=0.0031), with a median OS of 35.0 months (95% CI 28.8-38.9) in the enzalutamide arm compared to 42.3 months (95% CI 36.8-49.1) for XOFIGO plus enzalutamide. 1 The study will continue to the final OS analysis. XOFIGO is the first and only alpha emitting radiopharmaceutical that treats bone metastases in mCRPC approved by the U.S. Food and Drug Administration (FDA). 'PEACE III is the first major Phase III trial to combine an ARPI with radiopharmaceutical that showed statistical significance in meeting the primary endpoint,' said Denis Lacombe, Chief Executive Officer, EORTC. 'The EORTC is proud to be at the forefront of this groundbreaking trial, helping to redefine the development of clinical trials and supporting patient care for difficult to treat diseases.' The results were consistent with the established safety profile of XOFIGO, although authors noted the importance of administering bone protective agents (BPAs) to avoid fractures. Following the release of the ERA-223 results, the PEACE III study was amended in March 2018 making BPAs mandatory at the monthly skeletal-related-event dose. The observed reduction in fractures following this amendment underlined the importance of using a BPA in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastasis also in the era of ARPI's. 4 Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 65.6% of patients in the combination arm compared to 55.8% of patients who received enzalutamide alone. 1 The most frequent Grade 3 or higher TEAEs were hypertension (34%), fatigue (6%), fracture (5%), anemia (5%), and neutropenia (5%). 1 Fractures (either treatment-emergent or post-treatment, symptomatic or pathologic, or with or without BPA use) were reported in 24.3% of patients in the combination arm and 13.4% of patients in the enzalutamide arm. 1 These results demonstrate the potential for this combination to be a new treatment option for patients with mCRPC and bone metastases who have experienced disease progression on androgen deprivation therapy (ADT). 'There remains an unmet patient need for people living with metastatic castration-resistant prostate cancer who have bone metastases,' said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer's Pharmaceuticals Division. 'The PEACE III trial underscores our dedication to advancing therapies for patients with prostate cancer and exploring the full potential of XOFIGO.' Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for XOFIGO for the treatment of patients with mCRPC and who have bone metastases in combination with enzalutamide based on positive results from the Phase III PEACE trial. Bayer will submit applications for marketing authorizations of XOFIGO to additional health authorities as well. The trial is supported by Astellas and Pfizer who manufacture enzalutamide (Xtandi) in collaboration with Bayer. About PEACE III (EORTC GUCG-1333) The PEACE III trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. A total of 446 patients were randomized 1:1 to receive either XOFIGO 55 kBq/kg as an intravenous injection monthly for six cycles in combination with enzalutamide 160mg orally daily or enzalutamide 160mg orally daily. The primary endpoint was radiological progression-free survival (rPFS) by investigator assessment. Key secondary endpoints included overall survival (OS), time to subsequent systemic treatment, pain progression, and symptomatic skeletal event. This trial was a collaboration with several cancer cooperative groups: EORTC, CTI, CUOG, LACOG, and GETUG. About Xofigo ® (radium-223 dichloride) Injection 2 Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Important Safety Information for Xofigo ® (radium-223 dichloride) Injection Warnings and Precautions: Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo Secondary Malignant Neoplasms: Xofigo contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%). Please see the full Prescribing Information for Xofigo (radium Ra 223 dichloride). About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to © 2025 Bayer BAYER, the Bayer Cross and XOFIGO are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Tombal. B., et al. Enzalutamide plus Radium-223 in Metastatic Castration-Resistant Prostate Cancer: Results of the EORTC 1333/PEACE-3 trial. Annals of Oncology. May 30, 2025. DOI: 10.1016/ Gillessen, S., et al. A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3. European Society of Medical Oncology 2025 (ESMO) LBA1. September 9, 2024. Xofigo ® (radium-223 dichloride) Injection [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, December 2019. Gillessen S, et al. Decrease in Fracture Rate with Mandatory Bone-protecting Agents in the EORTC 1333/PEACE-3 Trial Comparing Radium-223 Combined with Enzalutamide Versus Enzalutamide Alone: A Safety Analysis. Eur Urol. 2025 Mar;87(3):285-288.
Yahoo
28-05-2025
- Business
- Yahoo
ORIC® Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC
Broad and deep PSA responses achieved, with 59% PSA50 response rate (confirmed rate of 47%, and one additional response pending confirmation) and 24% PSA90 response rate (all confirmed) in patients with mCRPC PSA responses were observed across all ORIC-944 dose levels and at comparable rates in combination with apalutamide and with darolutamide; majority of patients are still ongoing with multiple patients approaching one year or more Both combination regimens demonstrated a safety profile compatible with long term dosing, with the vast majority of adverse events Grade 1 or 2 Announced concurrent $125 million financing, which extends cash runway into 2H 2027 and through anticipated primary endpoint readout from first Phase 3 trial SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, May 28, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced potentially best-in-class preliminary efficacy and safety data from the ongoing Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). 'These ORIC-944 combination data demonstrate substantial clinical activity with both AR inhibitors, apalutamide and darolutamide, through early measures of efficacy (PSA50 and PSA90 response rates) and a safety profile consisting almost entirely of mild to moderate GI related adverse events, making it highly suitable for potential long term dosing,' said Pratik S. Multani, M.D., chief medical officer. 'The data generated to date continue to demonstrate the potential of ORIC-944 to be a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer,' said Jacob M. Chacko, M.D., president and chief executive officer. 'The efficacy and safety data presented today compare favorably to other PRC2 inhibitor data presented earlier this year. We look forward to subsequent updates from the dose exploration and dose optimization portion of the Phase 1b trial over the next three quarters as we move towards initiating our first global registrational trial in 1H 2026.' ORIC-944 Phase 1b Trial DesignORIC-944 is being evaluated in a Phase 1b dose exploration trial in combination with ERLEADA® (apalutamide), Johnson & Johnson's AR inhibitor, and NUBEQA® (darolutamide), Bayer's AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objectives of the trial are to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity. ORIC-944 Phase 1b Dose Exploration DataData include 17 patients with mCRPC previously treated with a median of three lines of prior therapy, including abiraterone, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include androgen deprivation therapy or first-generation androgen receptor deprivation therapy. Patients were treated once daily with 400 mg, 600 mg, or 800 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA response data are as of May 9, 2025. Preliminary activity analysis59% of patients (10/17) achieved a PSA50 response and nearly all patients with a PSA50 response were confirmed one month later, for a confirmed PSA50 response rate of 47% (8/17), which does not include one additional PSA response pending confirmation. 24% of patients (4/17) achieved a PSA90 response, all of which were subsequently confirmed. PSA responses were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide. The majority of patients are still ongoing with multiple patients approaching one year or more on therapy. Further dose exploration is ongoing. Preliminary safety analysisORIC-944 in combination with apalutamide or with darolutamide has been generally well tolerated to date, with a vast majority of adverse events (AEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of April 22, 2025, diarrhea was the most common treatment-related AE, occurring in 53% of patients (9/17) across all dose levels with only one patient experiencing a Grade 3 event. There were no Grade 4 or Grade 5 treatment-related AEs attributed to ORIC-944 with apalutamide or with darolutamide. Next StepsFollowing completion of the Phase 1b dose exploration portion of the trial expected in mid-2025, the company plans to evaluate two candidate RP2Ds for each combination in the dose optimization portion of the trial in 2H 2025. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC that the company expects to initiate in 1H 2026. Corporate UpdateThe company announced a concurrent $125 million private placement financing that it expects will extend cash runway into the second half of 2027 and through the anticipated primary endpoint readout from the first ORIC-944 Phase 3 registrational trial in mCRPC. The financing is expected to close on May 29, 2025, subject to customary closing conditions. Conference Call and Webcast DetailsORIC will host a conference call and webcast today at 4:30 p.m. ET. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. A live webcast and audio archive of the conference call will be available through the investor section of the company's website at The webcast will be available for replay for 90 days following the presentation. About ORIC-944ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) for prostate cancer (NCT05413421). 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) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking StatementsThis 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, statements regarding the continued clinical development of ORIC-944; statements regarding the potential best-in-class properties of ORIC-944; clinical outcomes from combination studies with ORIC-944, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-944 and ORIC's other product candidates; the potential advantages of ORIC-944 and ORIC's other product candidates and programs; plans underlying ORIC's clinical trials and development; next steps and anticipated program milestones, including timing of program and data updates and the initiation of the first ORIC-944 Phase 3 registrational trial in mCRPC; the anticipated timing of the primary endpoint readout from the first ORIC-944 Phase 3 registrational trial in mCRPC; the timing and expectation of the closing of the private placement financing; the satisfaction of customary closing conditions related to the private placement financing; the period over which ORIC estimates the proceeds from the private placement, combined with its existing cash, cash equivalents and marketable securities, will be sufficient to fund its current operating plan; and statements by the company's chief medical officer and 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 operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC's product candidates to differ from preclinical, initial, interim, preliminary or expected 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; 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 titled 'Risk Factors' in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the 'SEC') on May 5, 2025, 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
