On May 15, 2026 Bayer reported new data from the Phase II ARASEC trial show NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) resulted in a 71% reduction in the risk of progression or death per CHAARTED criteria compared to ADT alone (HR 0.29; 95% CI 0.20–0.40; P<0.001) in U.S. patients (N=320) with metastatic castration-sensitive prostate cancer (mCSPC). NUBEQA plus ADT was also associated with significant improvements in overall survival (OS) (HR 0.50; 95% CI 0.30–0.82; P=0.003), time to metastatic castration-resistant prostate cancer (mCRPC) (HR 0.26; 95% CI 0.18–0.38; P<0.001), and radiological progression-free survival (rPFS) (HR 0.30; 95% CI 0.19–0.48; P<0.001) vs a matched ADT alone arm from a historical control.1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Some notable limitations of the study include: open-label Phase II study design, the absence of randomization, and the use of historical external control. Primary results are being presented today as a plenary session during the American Urological Association (AUA) Annual Meeting.

NUBEQA is indicated in the U.S. for the treatment of adult patients with mCSPC, both with and without docetaxel, and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

In the ARASEC trial, no new safety signals were observed in the NUBEQA plus ADT arm, consistent with previous studies. Safety results were reported descriptively for the NUBEQA plus ADT arm only, as safety data were not routinely collected in the CHAARTED ADT-alone arm. In the NUBEQA plus ADT matched population, 58% of treatment-emergent adverse events (TEAEs) were grade 1/2 and 8% discontinued NUBEQA due to TEAEs.

"Results from the Phase II ARASEC trial provide additional evidence regarding the efficacy and safety of darolutamide plus ADT in patients with mCSPC," said Rana R. McKay, MD, Medical Oncologist and Professor of Medicine, Urology, and Radiation Medicine and Applied Sciences and Principal Investigator of the ARASEC trial. "The data further support NUBEQA’s ability to offer physicians and patients with prostate cancer a treatment option that is both effective and generally well tolerated."

Prostate cancer is the leading cancer diagnosis among men in the U.S.3 Around 313,780 men are diagnosed with prostate cancer each year and about 35,770 die from the disease in the U.S.3 By 2040, prostate cancer diagnoses are projected to increase to 2.9 million worldwide.4 For men with mCSPC, just over a third (~38%) will survive five years or more after diagnosis,5 and most progress to castration-resistant prostate cancer (CRPC), a condition with limited long-term survival.6,7

"The ARASEC trial was designed to further evaluate NUBEQA plus ADT in patients with metastatic castration-sensitive prostate cancer using a rigorous and innovative study approach," said Yesmean Wahdan, Senior Vice President and Head of Medical Affairs, U.S. and North America Pharmaceuticals at Bayer. "Supported by our robust clinical development program, these results add to the growing body of evidence demonstrating the efficacy and tolerability of NUBEQA and reinforce our commitment to expanding treatment options for patients earlier in the disease."

About the ARASEC trial8

ARASEC (NCT05059236), is a U.S. prospective open-label, multicenter, Phase II study with an external control arm, complementary to the ARANOTE trial. The study compares NUBEQA plus ADT with a historical external ADT-alone control arm. Patients with mCSPC on conventional imaging and no prior systemic therapy were prospectively enrolled to receive NUBEQA 600 mg twice daily plus ADT. Patients were matched 1:1 to patients enrolled on the ADT-alone arm of the Phase III CHAARTED study using propensity scores based on baseline prognostic characteristics (age, ECOG performance status, CHAARTED-defined extent of disease, prior local therapy, Gleason score, baseline prostate-specific antigen [PSA]). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), time to metastatic castration-resistant prostate cancer (mCRPC), radiological PFS (rPFS; based on imaging frequency as clinically indicated), PSA <0.2 ng/mL response rates, and safety (reported descriptively for the darolutamide plus ADT arm only, as safety data were not routinely collected in the CHAARTED ADT-alone arm).

Potential limitations of the study include: open-label Phase II study design, the absence of randomization, and the use of historical external control. Although propensity score matching was used, this method only adjusts for measured variables; unknown or unmeasured confounders may still remain. Use of a historical external control arm may introduce bias due to changes in standards of care over time, differences in endpoint definitions, and assessment methods.

About NUBEQA (darolutamide)2

NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA was developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
Metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, ischemic heart disease occurred in 3.4% of patients receiving NUBEQA and 2.2% receiving placebo, including Grade 3-4 events in 1.4% and 0.3%, respectively. Ischemic events led to death in 0.4% of patients receiving NUBEQA and 0.4% receiving placebo.

In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel and 0% receiving placebo with docetaxel.

Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – Seizure occurred in patients receiving NUBEQA.

In a pooled analysis of ARAMIS and ARANOTE, Grade 1-3 seizure occurred in 0.2% of patients receiving NUBEQA. Seizure occurred from 261 to 665 days after initiation of NUBEQA.

In ARASENS, seizure occurred in 0.8% of patients receiving NUBEQA with docetaxel, including two Grade 3 events. Seizure occurred from 38 to 1754 days after initiation of NUBEQA.

It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo. Fatal adverse reactions that occurred in ≥2 patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common (>2% with a ≥2% increase compared to placebo) adverse reactions, including laboratory test abnormalities, were increased AST (23%), decreased neutrophil count (20%), fatigue (16%), increased bilirubin (16%), pain in extremity (6%), and rash (4%). Clinically relevant adverse reactions occurring in 2% or more of patients treated with NUBEQA included ischemic heart disease (4%) and heart failure (2.1%).

In ARANOTE, serious adverse reactions occurred in 24% of patients receiving NUBEQA. Serious adverse reactions in ≥1% of patients who received NUBEQA included pneumonia (2%), urinary tract infection (1.8%), musculoskeletal pain (1.6%), hemorrhage (1.6%), arrhythmias (1.3%), and spinal cord compression (1.1%). Fatal adverse reactions occurred in 4.7% of patients receiving NUBEQA and those that occurred in ≥2 patients included sepsis (1.1%), craniocerebral injury (0.4%), and myocardial infarction (0.4%). The most common (≥10% with a ≥2% increase compared to placebo) adverse reaction is urinary tract infection (12%). The most common laboratory test abnormalities (≥15% with a ≥5% increase over placebo) are increased AST (32%), increased ALT (28%), increased bilirubin (17%), and decreased neutrophil count (16%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA included arrhythmia (8.8%), pneumonia (3.6%), and myocardial infarction (0.7%).

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), neutrophil count decreased (2.8%), musculoskeletal pain (2.6%) and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel. Fatal adverse reactions in ≥2 patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common (≥10% with a ≥2% increase over placebo with docetaxel) adverse reactions are constipation (23%), rash (20%), decreased appetite (19%), hemorrhage (18%), increased weight (18%), and hypertension (14%). The most common laboratory test abnormalities (≥30%) are anemia (72%), hyperglycemia (57%), decreased lymphocyte count (52%), decreased neutrophil count (49%), increased AST (40%), increased ALT (37%), and hypocalcemia (31%). Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures (8%), ischemic heart disease (3.2%), seizures (0.6%), and drug-induced liver injury (0.3%).

Drug Interactions

Effect of Other Drugs on NUBEQA – Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity. Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers.

Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.

Effects of NUBEQA on Other Drugs – NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions, and consider dose reduction of the BCRP substrate drug.

NUBEQA is an inhibitor of OATP1B1 and OATP1B3 transporters. Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor patients more frequently for adverse reactions of these drugs and consider dose reduction while patients are taking NUBEQA.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Castration-Sensitive Prostate Cancer

Prostate cancer is the leading cancer diagnosis among men in the U.S.3 Around 313,780 men are diagnosed with prostate cancer each year and about 35,770 die from the disease in the U.S.3

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mCSPC is an advanced form of prostate cancer, when the cancer has spread beyond the prostate to other organs but is still responding to hormone therapy that lowers testosterone, such as androgen deprivation therapy (ADT). Despite treatment, most men with mCSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival.

(Press release, Bayer, MAY 15, 2026, View Source [SID1234665799])

On May 15, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that the U.S. Food and Drug Administration (FDA) has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq) immunotherapy in MIBC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is the first companion diagnostic approval in the field of blood-based MRD. It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in which treatment decisions may depend on Signatera MRD status, and interventions may be delayed or deferred for patients who remain MRD-negative. Supported by more than 185 peer-reviewed publications and Medicare coverage across multiple cancer types (including Bladder, Breast, Lung, Colorectal, Ovarian, and pan-cancer immunotherapy monitoring), Signatera has become a cornerstone of precision oncology.

Signatera CDx has been approved by the FDA for use with adjuvant atezolizumab (Tecentriq) to identify patients with MIBC who are ctDNA MRD-positive and may benefit from treatment. This follows The New England Journal of Medicine publication in October 2025 of the landmark, global Phase III IMvigor011 trial, sponsored by Genentech. The trial results demonstrated that Signatera MRD-positive patients treated with immunotherapy achieved significant improvements in disease-free survival (DFS) and overall survival (OS), while Signatera MRD-negative patients achieved 97% 2-year OS with no adjuvant therapy at all.

"The practice-changing IMvigor011 trial and this approval signal a transformation in cancer care, where MRD is guiding when to treat, whom to treat, and how to treat more precisely," said Professor Thomas Powles, lead principal investigator of IMvigor011 and Chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Historically, we relied on imaging to tell us when cancer had returned, but that also meant millions of cancer cells were already present in the body. As we saw with IMvigor011 and in several other trials, Signatera detected tumor DNA at an earlier timepoint and provided us with a significant head start to improve outcomes for patients."

"For bladder cancer patients and families, the period after bladder removal can be filled with uncertainty," said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network. "Approaches like Signatera can help clarify which patients are more likely to experience recurrence, giving clinicians additional important information as they consider next steps. Our priority is ensuring that patients and families have access to tools that support informed decision-making, reduce unnecessary treatment when possible, and help guide timely care when it’s needed."

"This FDA approval is a major milestone for the field of precision oncology and personalized medicine," said Solomon Moshkevich, president of clinical diagnostics at Natera. "This validates the vision that Natera introduced 10 years ago and solidifies Signatera MRD as the new standard of care in muscle-invasive bladder cancer. With our growing portfolio of TOMR trials and our recent innovations in ultrasensitive genome-based MRD and phased variant technologies, Natera continues to drive forward the science across all cancer types."

There are approximately 30,000 new diagnoses of MIBC each year in the U.S. and 150,000 globally.1-5 Radical cystectomy, with or without neoadjuvant therapy, is associated with long-term disease control in approximately half of patients with muscle-invasive bladder cancer, but it has historically been difficult to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing others from unnecessary treatment.5-6 With IMvigor011, there is now prospective evidence showing that MRD can guide care for patients in this setting and adds to the growing body of evidence on Signatera across the bladder cancer continuum.

(Press release, Natera, MAY 15, 2026, View Source [SID1234665798])

On May 15, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) will be presented as an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress. The abstract is now available on the EHA (Free EHA Whitepaper) Congress platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

The abstract data demonstrated that the ligufalimab-based triplet regimen delivered encouraging efficacy, with significant improvements in survival outcomes. The combination also showed a manageable safety profile, offering a potentially better-tolerated treatment option for this vulnerable patient population.

As of the November 2025 data cutoff, key findings included:

Deep and Durable Tumor Remission

The objective response rate (ORR) was 80.0% in the ligufalimab arm versus 66.7% in the control arm, with a composite complete remission (CRc) rate of 56.7% versus 53.3%. Among patients achieving CRc, the measurable residual disease (MRD) negativity rate was higher in the ligufalimab arm (46.7% versus 36.7%).
Median duration of CRc was substantially longer in the ligufalimab arm at 10.4 months versus 6.5 months in the control arm.
Encouraging Survival Benefit Trend

At a median follow-up of 8.84 months, median overall survival (mOS) in the ligufalimab arm was not yet reached, versus 8.3 months in the control arm. The 9-month overall survival rate was 78.7% in the ligufalimab arm versus 43.1% in the control arm; the 6-month OS rates were 83.3% versus 73.2%, respectively.
Favorable Safety Profile With No New Safety Signals Observed

The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy.
Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors.

(Press release, Akeso Biopharma, MAY 15, 2026, View Source [SID1234665797])

On May 15, 2026 Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m2 of RC220 as monotherapy, or 40mg/m2 of RC220 in combination with 60mg/m2 of doxorubicin, in the first patient cohort of this groundbreaking trial.

"The SRC’s unanimous recommendation to proceed with the trial, along with the absence of any safety concerns, represents an important milestone for this clinical program," said Daniel Tillett, CEO of Racura Oncology. "These findings support the continued advancement of RC220 into the next cohorts of this study. We wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial."

Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.

The Company has received the SRC’s formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria.

About Cardioprotection and Anticancer Synergy (CPACS) Trial

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery that RC220 can provide protection from anthracycline cardiotoxicity while improving the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients using a Bayesian design. The effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. This open-label trial is being conducted across multiple sites in Australia, Hong Kong, and South Korea.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

(Press release, Racura Oncology, MAY 15, 2026, View Source [SID1234665796])

On May 15, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported Dave Lennon, PhD, President and CEO, will participate in a virtual fireside chat as part of the 2026 Stifel Virtual Targeted Oncology Forum on Tuesday, May 19, 2026, at 3 PM ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the event can be accessed by visiting the Whitehawk Therapeutics IR website and will be available for replay for approximately 30 days following the event.

(Press release, Whitehawk Therapeutics, MAY 15, 2026, View Source [SID1234665795])