[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of apalutamide tablets in healthy trial participants, conducted in both fasting and postprandial states.

主要试验目的：通过健康试验参与者在空腹/餐后状态下分别单次口服广东东阳光药业股份有限公司的阿帕他胺片（60 mg，受试制剂）与Janssen-Cilag International NV持证、Janssen Ortho, LLC生产的阿帕他胺片（商品名：安森珂®，60 mg，参比制剂）进行人体生物等效性试验，评价受试制剂与参比制剂的生物等效性。次要试验目的：评价中国健康试验参与者单次空腹/餐后口服阿帕他胺片受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of apalutamide tablets (60 mg, test formulation) manufactured by Guangdong Dongyangguang Pharmaceutical Co., Ltd., and apalutamide tablets (trade name: Ansenke®, 60 mg, reference formulation) manufactured by Janssen Ortho, LLC and licensed by Janssen-Cilag International NV, in healthy participants under fasting/postprandial conditions. Secondary objective: To evaluate the safety of apalutamide tablets (test formulation and reference formulation) after a single oral administration in healthy Chinese participants under fasting/postprandial conditions.

Start Date20 Apr 2026

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

NCT07333066

/ Not yet recruitingPhase 3IIT

Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.

This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng/ml or PSA90 response in combination with a PSA ≤ 4 ng/ml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA > 0.2 ng/ml in combination with a PSA response < 90%, or a PSA response ≥90% in combination with a PSA > 4 ng/ml.

Start Date31 Mar 2026

Sponsor / Collaborator

Apices Soluciones SL

100 Clinical Results associated with Apalutamide

100 Translational Medicine associated with Apalutamide

100 Patents (Medical) associated with Apalutamide

805

Literatures (Medical) associated with Apalutamide

01 Jun 2026·PROSTATE

The Prognostic Significance of Radiographic Progression Without PSA Progression in Patients With Metastatic Hormone‐Sensitive Prostate Cancer Treated With First‐Line ARPI Therapy

Article

Author: Nishio, Kyosuke ; Kimura, Takahiro ; Yoshikawa, Yuki ; Azuma, Haruhito ; Tsutsumi, Takeshi ; Yoshizawa, Atsuhiko ; Inamoto, Teruo ; Fumihiko Urabe ; Nakamori, Keita ; Saruta, Masanobu ; Toyoda, Shingo ; Matsunaga, Tomohisa ; Uchimoto, Taizo ; Fukushima, Tatsuo ; Fujita, Kazutoshi ; Yamazaki, Shogo ; Sakamoto, Moritoshi ; Matsuda, Takuya ; Takahara, Kiyoshi ; Yanagisawa, Takafumi ; Nishimura, Kazuki ; Komura, Kazumasa ; Tsujino, Takuya ; Maenosono, Ryoichi ; Nakamura, Ko ; Mori, Keiichiro ; Fukuokaya, Wataru ; Fujimoto, Saizo

ABSTRACT:

Background:

Radiographic progression (RP) without prostate‐specific antigen (PSA) elevation has emerged as a clinically important pattern in the androgen receptor pathway inhibitors (ARPI) era, but its prevalence and prognostic significance in real‐world metastatic hormone‐sensitive prostate cancer (mHSPC) cohorts remain unclear.

Objective:

To assess the prevalence and prognostic implications of RP alone progression in mHSPC patients treated with first‐line ARPIs.

Methods:

We retrospectively analyzed 518 mHSPC patients treated with abiraterone acetate plus prednisolone, enzalutamide, or apalutamide. PSA progression was defined using PCWG3 criteria. Patients were categorized into PSA progression or RP alone progression groups, and clinical outcomes were compared.

Results:

Among 169 patients who developed castration‐resistant prostate cancer (CRPC), 34 (20.1%) experienced RP alone. RP alone patients had significantly worse overall survival compared to those with PSA progression (median 21 vs. 39 months, p = 0.007), despite exhibiting deeper biochemical responses—PSA nadir (0.055 vs. 0.86 ng/mL, p < 0.001) and a higher rate of PSA nadir < 0.2 ng/mL (61.8% vs. 27.4%, p < 0.001). The baseline characteristic differing between groups was CHAARTED volume classification; high volume disease was markedly more common in RP alone patients (94.1% vs. 77.8%). In univariate and multivariate analyses of the overall cohort, CHAARTED high volume disease was identified as an independent risk factor for RP alone (HR 10.3, 95% CI 1.20–89.3; p = 0.034).

Conclusion:

RP alone progression occurred in approximately one‐fifth of patients and was associated with significantly poorer survival despite excellent PSA responses, underscoring the limitation of PSA‐based monitoring and supporting routine imaging for early detection of PSA‐incongruent disease progression in mHSPC.

01 Jun 2026·Clinical Genitourinary Cancer

Real-World Effectiveness and Treatment Persistence of Darolutamide, Apalutamide, and Enzalutamide in Non-Metastatic Castration-Resistant Prostate Cancer: A Multicenter Study

Article

Author: Urabe, Fumihiko ; Kimura, Takahiro ; Yata, Yuji ; Kawano, Shota ; Yamada, Hiroki ; Hashimoto, Masaki ; Imai, Yu ; Kurawaki, Shiro ; Otsuka, Takashi ; Mori, Keiichiro ; Iwamoto, Yuya ; Atsuta, Mahito ; Miyajima, Keiichiro ; Hara, Shuhei ; Ishikawa, Mimu ; Tsuzuki, Shunsuke ; Yanagisawa, Takafumi ; Fukuokaya, Wataru ; Kurokawa, Gaku ; Nakazono, Minoru ; Shimomura, Tatsuya

INTRODUCTION:

Three androgen receptor signaling inhibitors (ARSIs), darolutamide (DAR), apalutamide (APA), and enzalutamide (ENZ), are standard treatments for non-metastatic castration-resistant prostate cancer (nmCRPC); comparative real-world data on treatment persistence and safety remain limited.

PATIENTS AND METHODS:

We retrospectively analyzed 343 Japanese patients with nmCRPC treated with DAR (n = 92), APA (n = 64), or ENZ (n = 187) across 16 institutions. Oncological outcomes, including PSA progression-free survival (PSA-PFS) and PFS, were compared using multivariable Cox regression to adjust for baseline imbalances. Treatment persistence was evaluated by time to treatment discontinuation (TTD) and reasons for discontinuation.

RESULTS:

The ENZ group had significantly worse baseline characteristics than the other groups. After multivariable adjustment, DAR showed consistently favorable hazard ratios for PSA progression (HR, 0.55, P = .038) and disease progression (HR, 0.59, P = .047) compared with ENZ; however, these differences were attenuated and no longer statistically significant after PSM (PSA-PFS HR, 0.62, P = .119), suggesting broadly comparable oncological outcomes across agents. Median TTD was significantly shorter in the APA group (11.0 months) compared with the DAR (27.0 months) and ENZ (25.0 months) groups (P = .019). Discontinuation due to adverse events was significantly more frequent in APA (51.6%) than DAR (19.6%) or ENZ (18.8%), primarily due to skin rash. Among discontinuers, AEs were the primary reason in 82.5% of APA, 42.9% of DAR, and 41.7% of ENZ.

CONCLUSION:

In this real-world cohort, all 3 ARSIs demonstrated broadly comparable oncological outcomes, consistent with PSM. The principal differentiator was treatment persistence: APA was limited by markedly shorter TTD (median 11.0 months), primarily driven by skin rash; this difference was numerically preserved after PSM, though it did not reach statistical significance in the smaller matched sample. The high frequency of APA-related rash (46.9%) is consistent with prior Japanese/East Asian reports, including the integrated SPARTAN/TITAN Japanese analysis, and should be prioritized in treatment selection and patient counseling.

01 Jun 2026·European Urology Open Science

PSA Response as a Prognostic Factor of Overall Survival in Patients with Metastatic Hormone-sensitive Prostate Cancer Treated with Apalutamide: Real-world Evidence

Article

Author: Picola, Natalia ; Pazos, Darío Vázquez-Martul ; Jiménez, Estíbaliz ; Hernández, Virginia ; Planells, Marc Costa ; Rivas, Juan Gómez ; Herrera, Bernardo ; Expósito, Nagore García ; Linares, Estefanía ; Márquez, Meritxell Pérez ; Pablos-Rodríguez, Pedro De ; Esteban, Mario Domínguez ; Bonet, Ángeles Sanchis ; Resa, Laura ; Sopeña, Raquel ; Llorente, Carlos ; De la Morena, José Manuel ; Vilaseca, Antoni ; Vives, Pol Servián ; Guijarro, Ana ; la Peña, Enrique De ; Rodríguez, Jesús Muñoz

Background and objective:

Prostate-specific antigen (PSA) decline has been proposed as a prognostic marker in metastatic hormone-sensitive prostate cancer (mHSPC). We aimed to evaluate whether a ≥90% PSA decline (PSA 90) predicts overall survival (OS) in patients treated with apalutamide plus androgen deprivation therapy (ADT) in real-world practice. Design, setting, and participants; Intervention (include if there are any).

Outcome measurements and statistical analysis:

We conducted a multicenter retrospective study including patients with mHSPC treated with apalutamide plus ADT in 17 hospitals. PSA 90 was defined as a ≥90% decline from baseline within 3 or 6 mo or PSA <0.02 ng/ml. To evaluate the effect of PSA response, a landmark analysis was performed at 3 and 6 mo. We evaluated OS and radiographic progression-free survival (rPFS). Multivariable Cox regression analyses were adjusted for age, baseline PSA, disease presentation (de novo vs recurrent), volume (CHAARTED), and risk (LATITUDE).

Results and limitations:

Between May 2018 and September 2024, 1022 patients with mHSPC were included in the Real-World Evidence APA database. The median age was 68.5 yr (interquartile range [IQR] 62.7-74.6) and baseline PSA 8.2 ng/ml (IQR 1.8-41.1). At 3 mo, 807 patients (87%) achieved a PSA 90 response; at 6 mo, 773 patients (88%) were PSS 90 responders. PSA 90 response at 3 and 6 mo was associated with a statistically significant lower hazard of OS (hazard ratio [HR] = 0.31, 95% confidence interval [CI] = 0.19-0.51). Similar results were observed for PSA 90 at 6 mo (HR = 0.29, 95% CI = 0.17-0.48). PSA 90 response at 3 and 6 mo was also associated with a statistically significant lower hazard of rPFS response (HR = 0.46, 95% CI = 0.31-0.69, and HR = 0.41, 95% CI = 0.26-0.63, respectively). Limitations include the retrospective design, potential selection bias, incomplete PSA measurements, heterogeneity in imaging, and shorter follow-up, which may affect the precision and generalizability of our findings.

Conclusions:

PSA 90 response at 3 and 6 months is a strong prognostic marker for overall survival and radiographic progression-free survival in patients with metastatic hormone-sensitive prostate cancer treated with apalutamide. These findings support PSA 90 as an early prognostic indicator for clinical risk stratification. Patient summary: We studied how blood levels of PSA change in men with advanced prostate cancer treated with apalutamide. Patients whose PSA dropped by 90% or became undetectable within 3 or 6 mo lived longer, suggesting that early PSA reduction can help predict better outcomes.

197

News (Medical) associated with Apalutamide

03 Jun 2026

·ir.actiniumpharma.com

Actinium Pharmaceuticals Oral Presentation at SNMMI 2026 Highlights ATNM-400 Overcoming Resistance to All Three Approved Androgen Receptor Inhibitors and Offers Flexible, Well-Tolerated Dosing in Prostate Cancer Models

New data demonstrated ATNM-400 remains potently active in prostate cancer cells and tumors resistant to all three approved androgen receptor inhibitors (ARPIs) -enzalutamide (Xtandi®), apalutamide (Erleada®), and darolutamide (Nubeqa®)- directly targeting the point of failure for a high proportion of mCRPC patients ATNM-400 substantially outperformed apalutamide and darolutamide in an ARPI-resistant tumor model, and in combination with either ARPI it showed durable complete responses, supporting both monotherapy and combination strategies in refractory disease similar to prior data with enzalutamide ATNM-400 delivered superior tumor control as a single bolus or repeat dose with a consistent safety profile and minimal off-target toxicity across treatment regimens, indicating dosing flexibility and a wide therapeutic window that could de-risk clinical translation. In high PSMA expressing disease, ATNM-400 outperformed 177Lu-PSMA-617 in terms of activity and was similar to 225Ac-PSMA-617. However, as its target is not expressed in the salivary glands, ATNM-400 is not expected to cause xerostomia which is a key limitation of PSMA directed therapies NEW YORK, June 3, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, on June 2, 2026, presented new data on ATNM-400 in prostate cancer at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting taking place in Los Angeles, California. Androgen receptor pathway inhibitors (ARPIs) such as enzalutamide (Xtandi®, Astellas/Pfizer), apalutamide (Erleada®, Johnson & Johnson), and darolutamide (Nubeqa®, Bayer) are foundational to advanced prostate cancer care, but virtually all patients eventually develop resistance and progress -with up to 50,0001 patients per year exhausting ARPI therapy- creating a large and recurring unmet need. ATNM-400, Actinium's first-in-class Actinium-225 antibody radioconjugate, targets a non-PSMA antigen linked to aggressive prostate cancer biology and delivers a high-energy alpha-particle payload that kills tumor cells through a mechanism independent of PSMA expression and androgen receptor signaling. In preclinical head-to-head studies, this PSMA-independent mechanism allowed ATNM-400 to match or exceed PSMA-targeted radioligand therapies, including 177Lu-PSMA-617 (active ingredient of Pluvicto®, Novartis) and 225Ac-PSMA-617, across PSMA-high, PSMA-low, and PSMA-negative models. _______________________________ 1 Candelieri-Surette D, Lee J, Lynch JA, et al. Epidemiology of Metastatic Castration-Resistant Prostate Cancer in Veterans Nationwide. J Natl Compr Canc Netw. 2025;23(8):307–313. doi:10.6004/jnccn.2025.7032. The new data presented at SNMMI 2026 address three key questions: whether ATNM-400 can overcome ARPI resistance in the mCRPC setting, whether it works as both a single agent and in combination, and how its dosing and safety profile support translation to patients. The data answer each: ATNM-400 remained potent against cells and tumors resistant to all three approved ARPIs, achieved 94% tumor growth inhibition as a single agent and durable complete responses in combination, and maintained a consistent, clean safety profile across both single-bolus and repeat-dose regimens. Prostate cancer is one of oncology's largest commercial opportunities: androgen receptor pathway inhibitors generate more than $12 billion in annual sales in 2025 and Pluvicto® (177Lu-PSMA-617) reached $2.0 billion in 2025, yet up to 50,0001 patients exhaust ARPI therapy each year and roughly 30% of mCRPC patients are ineligible for PSMA-directed therapy. Because ATNM-400 acts independently of both androgen receptor signaling and PSMA, it is positioned to serve the full mCRPC continuum, from patients who have failed ARPIs to the PSMA-low and PSMA-negative populations with no approved targeted radiotherapy today. Actinium estimates this represents a combined opportunity of more than 100,000 patients annually, addressable as a monotherapy or in combination with existing standards of care. Sandesh Seth, Actinium's Chairman and CEO, said, "ARPI resistance is a central problem in advanced prostate cancer as once these drugs stop working there are few good options left. The new data are compelling as ATNM-400 stayed potent in cells and tumors resistant to all three approved ARPIs, outperformed apalutamide and darolutamide on its own similar to previous data with enzalutamide, and produced durable complete responses when combined with them. Equally important for development, ATNM-400 worked across single-dose and repeat-dose regimens with a consistent, clean safety profile, giving us real flexibility as we move toward the clinic. We believe these findings position ATNM-400 as a differentiated option for patients who have run out of ARPI choices. The same resistance-targeting biology underlies the compelling activity we have reported in non-small cell lung cancer and breast cancer, positioning ATNM-400 as a potential pan-tumor backbone for large, resistance-driven patient populations, alone or in combination. We look forward to sharing additional data across these programs in the coming months as we advance ATNM-400 toward the clinic." Highlights from the SNMMI 2026 Poster Presentation Poster Titled: ATNM-400: A First-in-Class Non-PSMA Actinium-225 Antibody Radioconjugate Demonstrates Superior Efficacy to PSMA-617 Radioligands and ARPIs With Favorable Safety Profile in Prostate Cancer Models New data presented at SNMMI 2026 highlight several findings central to ATNM-400's development in prostate cancer: In a low-PSMA, moderate-target tumor model (22Rv1), a single bolus dose of ATNM-400 (40 or 30 µCi/kg) delivered superior tumor control versus fractionated dosing, and a repeat 30 µCi/kg regimen sustained tumor control and survival through day 60 with all regimens outperforming 177Lu-PSMA-617 and showing minimal deviation from vehicle in blood, liver, and kidney safety markers. Flexible, well-tolerated dosing gives clinicians multiple ways to balance efficacy and safety and points to a wide therapeutic window. ATNM-400 produced potent, dose-dependent killing of prostate cancer cells that are resistant to enzalutamide, apalutamide, and darolutamide, driving cell viability toward zero after each ARPI had failed, while the ARPIs alone left the resistant cells largely intact. Demonstrating activity specifically after ARPI failure addresses the most common point of progression in advanced prostate cancer and supports ATNM-400 as a treatment option for patients with few alternatives. As monotherapy in an ARPI-resistant tumor model (22Rv1), ATNM-400 achieved 94% tumor growth inhibition versus just 32% for apalutamide and 5% for darolutamide, roughly three- to eighteen-fold greater tumor control than the ARPIs themselves. Working on its own in tumors that no longer respond to standard ARPIs positions ATNM-400 as a potential stand-alone therapy after resistance, not only an add-on. In combination with either apalutamide or darolutamide in the same ARPI-resistant model, ATNM-400 delivered durable tumor control at 107% tumor growth inhibition, with complete responses in at least 57% of mice (4/7 and 5/7). Turning resistant tumors into complete responses by pairing ATNM-400 with the very drugs that had failed supports a combination strategy that could extend the commercial and clinical value of approved ARPIs. In a high-PSMA, high-target tumor model (C4-2), ATNM-400 matched or exceeded both PSMA-targeted radioligands-comparable to 225Ac-PSMA-617 and superior to 177Lu-PSMA-617-while being given at roughly one-thousandth the administered radioactivity of 177Lu-PSMA-617 (40 µCi/kg versus 40 mCi/kg), with durable survival and favorable tolerability. Because ATNM-400 acts independently of PSMA, this activity carries across PSMA-high, PSMA-low, and PSMA-negative models, reaching the PSMA-variable patients that PSMA-directed radioligand therapy serve least well. Moreover as the ATNM-400 target is not expressed in the salivary glands xerostomia, a limitation of PSMA directed therapies and especially PSMA-Ac-225 based agents, is not expected. About Actinium Pharmaceuticals, Inc. Actinium is a pioneer in targeted radiotherapies designed to improve outcomes for patients with cancer. The company employs a biology-driven approach to develop differentiated radiopharmaceuticals for solid tumors and hematologic malignancies. Its mission is to transform cancer treatment through innovative radioconjugates that maximize therapeutic efficacy while minimizing toxicity to healthy tissue by combining expertise in tumor biology, translational medicine, and radiochemistry. Since inception, Actinium has focused on developing innovative radiotherapies. Its pipeline reflects this strategy across three areas: (1) solid tumor therapeutics including ATNM-400 and Actimab-A with pan-tumor potential; (2) Actimab-A as a therapeutic backbone for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in collaboration with the National Cancer Institute (NCI); and (3) targeted conditioning agents including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapy conditioning. ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. For more information, please visit www.actiniumpharma.com. Forward-Looking Statements This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements, including statements as related to regaining compliance with the rules of the NYSE American and submission of a compliance plan, are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. Investors: investorrelations@actiniumpharma.com View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-oral-presentation-at-snmmi-2026-highlights-atnm-400-overcoming-resistance-to-all-three-approved-androgen-receptor-inhibitors-and-offers-flexible-well-tolerated-dosing-in-prostate-cancer-models-302789403.html SOURCE Actinium Pharmaceuticals, Inc. Released June 3, 2026

Clinical Result

02 Jun 2026

·pmlive.com

J&J’s Erleada prostate cancer study shows significant reduction in risk of metastasis

Johnson & Johnson (J&J) has announced results from the final analysis of the phase 3 PROTEUS study showing that Erleada (apalutamide) plus hormone therapy (androgen deprivation therapy) significantly improved key short- and long-term clinical outcomes, versus placebo plus hormone therapy, for patients with high-risk localised or locally advanced disease. The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9% vs. 1.0% pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20% and extended the time before patients required subsequent therapy to more than six years. Henar Hevia, Senior Director, EMEA Therapeutic Area Head, Oncology at Johnson & Johnson, said: “Our ambition is to continue advancing therapies into earlier lines of treatment, where intervention may have the greatest potential to alter the course of disease,” said “By building on the established role of surgery with innovative systemic approaches, like apalutamide plus hormone therapy, we are helping drive a more proactive treatment strategy, tailored to patients’ evolving needs and ultimately aimed at delivering more durable outcomes.” Surgery to remove the prostate (radical prostatectomy) is one of the standard treatments for patients with high-risk localised or locally advanced disease, alongside radiation therapy. Yet nearly half of patients who undergo curative-intent surgery will see their cancer return, requiring additional treatment and moving beyond the point where cure is possible. Additional therapies are often used only after the cancer has spread, missing a critical window to intervene earlier and improve long-term outcomes. Yusri Elsayed, Global Therapeutic Area Head, Oncology at Johnson & Johnson, commented: “These findings point to a new potential way of treating patients with high-risk localised or locally advanced prostate cancer. We are now seeing the impact of apalutamide when used earlier, alongside surgery. As the first therapy in its class to show benefit in this setting, the data reinforces apalutamide’s differentiated profile and the need to move beyond a surgery‑only approach to treating earlier and improving long‑term outcomes.” These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.

Clinical ResultASCOPhase 3

02 Jun 2026

·www.biopharmadive.com

ASCO ‘26: Bispecifics vs. ADCs, a ‘RAS’ revolution and a step change in prostate cancer

CHICAGO The American Society of Clinical Oncologys annual meeting always features data with the potential to change clinical practice. This years meeting, though, was headlined by the kind of medical breakthrough cancer researchers have waited years for and progress for another class of medicine many believe to hold similarly standout potential.These two headlining presentations from Revolution Medicines in pancreatic cancer and Akeso and Summit Therapeutics in lung cancer dominated the discussion at McCormick Place on Sunday. But they were also just two of hundreds of studies that sparked debate that carried on outside presentation rooms and across convention center hallways, as well as at sales meetings, dinner tables and cocktail parties.Below are three storylines that emerged from ASCO.A bispecific vs. ADC clashBispecific antibodies and antibody-drug conjugates have exploded in popularity in recent years, in part, for their potential to upend more traditional methods of cancer treatment. Bispecifics, as their name suggests, can get after two troublesome targets instead of one. And antibody-drug conjugates, or ADCs, are a form of precision chemotherapy designed to squarely aim tumor-killing toxins at cancer cells while sparing healthy tissue.Both drug types have been approved for multiple malignancies. But at ASCO this year, a battle began brewing between them in one of oncologys most competitive landscapes.Over the weekend, Merck & Co. and Akeso presented dueling datasets testing a bispecific and an ADC, respectively, in non-small cell lung cancer. Both were from Phase 3 trials in China that, if replicated in global studies, could enable their therapies to become essential front-line treatments.Leading up to the meeting, analysts and investors parsed through the details from Merck and partner Kelun Biotechs study of the ADC sac-TMT, and the implications its progress might have for Akeso and collaborator Summits bispecific ivonescimab. But at ASCO, some attendees were more skeptical that an ADC like sac-TMT would measure up.Though ADCs are designed to be safer than traditional chemotherapy, theyre still associated with side effects. Those toxicities come from the chemotherapy payload, and their severity can depend on how well the ADC keeps it out of systemic circulation, where it can cause broader harm. In the case of sac-TMT, some of those side effects include lung inflammation as well as mouth sores known as stomatitis.Some argue that, by comparison, the side effects a bispecific like ivonescimab adds when paired with a Keytruda-like drug may not be as burdensome. “You're not adding a lot of toxicity, and youre increasing the efficacy fairly substantially, said John Heymach, chair of thoracic and head and neck cancer care at MD Anderson Cancer Center, in an interview. (Heymach is an investigator in a study involving ivonescimab.)But not all ADCs have these toxicities. And in those that do, the side effects can often be proactively managed by treating physicians. Patients can be given eye drops to manage swelling in ocular tissue, ice chips during infusions and steroid-based mouth washes to reduce mouth soreness. They can also be educated to look for signs of lung problems, such as shortness of breath.You have to know what the toxicities are going to be and how to get patients through that treatment safely, which can certainly be done with some foresight and planning, said Krushangi Patel, a City of Hope oncologist, speaking in an interview about a different ADC called Datroway. Jonathan GardnerThe RAS revolutionRAS, a family of genes that, when mutated, drive a constellation of tumors, has long been seen as an unattainable Holy Grail of cancer research. But a series of recent discoveries have shown RAS mutations can finally be successfully targeted with drugs.Revolution Medicines pancreatic cancer medicine daraxonrasib is at the forefront of this scientific progress, but many more RAS-targeting drugs are quickly following, prompting Rachna Shroff, the hematology and oncology chief at the University of Arizonas Cancer Center to declare to journalists that the RAS revolution is here.Revolutions results which showed daraxonrasib nearly doubled survival in patients with a notoriously fast-moving and deadly disease drew a rare and spontaneous standing ovation at ASCO on Sunday. Jennifer Knox of the University of Toronto, the oncology expert ASCO asked to provide outside commentary, called the slide depicting that finding an absolutely beautiful curve.This is the first glimpse at the real power of targeting RAS in pancreas cancer, Knox said.Knox lamented the fact that many people in the setting daraxonrasib could be approved for second-line treatment, following an initial round of chemotherapy may die or decline too quickly before theyre eligible. Still, the data provide hope for whats to come. Revolution is already testing daraxonrasib in newly diagnosed patients. And more than 20 companies, including Roche, Eli Lilly, Amgen, Boehringer Ingelheim and BeOne Medicines, are following with different, experimental RAS-targeting drugs.That all suggests the story is just beginning, said Brian Wolpin, a medical oncologist at Dana-Farber Cancer Institute and the daraxonrasib trials lead investigator.A RAS mutation is the founding event of pancreatic cancer, and now we've shown that you can drug that, and you can clearly benefit patients, he said.The next step will be science that lets us have long, durable responses and ultimately cure patients, Wolpin added, and I think it's here. Jonathan GardnerA paradigm shift in prostate cancerProstate cancer is often such a slow-growing tumor that it can be dealt with via active surveillance rather than any type of intervention. But in aggressive or high-risk cases, surgery to remove the prostate gland and some surrounding tissue can come next.For decades, that procedure has been the one way to effectively eliminate prostate cancer. But its not a cure-all; up to half of patients experience a recurrence within five years.Study results from Johnson &Johnson suggest there may be a new option ahead. In a Phase 3 trial called PROTEUS, the pill Erleada, when combined with a hormone therapy before and after prostate surgery, reduced the relative risk of disease progression and death by 20% compared to standard treatment. Patients who received it were nine-times more likely to have no cancer remaining at the time of their surgery. Treatment also helped lengthen the time before recipients needed additional treatment, according to findings presented at a plenary session on Sunday and simultaneously published in The New England Journal of Medicine.You have that moment where you could potentially give this patient curative-intent treatment, but once recurrence occurs, you've lost that opportunity, said Mark Wildgust, J&Js vice president of global medical affairs for oncology, in an interview. We had a conviction that Erleada was really different.Erleada is already approved for two different, advanced stages of prostate cancer and is now a blockbuster medicine for J&J. The drug brought in over $3.5 billion in revenue last year, a 19% jump from 2024, and generated $949 million in the first quarter of 2026.The latest data could drive those numbers much higher, making Erleada available to a much earlier, larger localized-disease population, wrote Leerink Partners David Risinger. Various sources estimate that about 50,000 people in the U.S. are diagnosed each year, he added in a Monday note to clients.Treatment does come with caveats. Rates of serious adverse events, as well as treatment-related discontinuations, were higher among Erleada recipients. Wildgust, however, said combining Erleada with existing care only added a little bit more rash.But he believes the biggest challenge ahead for J&J will be convincing physicians to change practice and just changing peoples minds.Theres going to be a lot of questions, and were ready to support them in answering those questions, he said. Delilah Alvarado '

Phase 3Clinical ResultASCO

100 Deals associated with Apalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11040	Apalutamide	L02BB05	DB11901

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Japan	Janssen Pharmaceutical KK	29 May 2020
Metastatic castration-resistant prostate cancer	United States	Janssen Biotech, Inc.	17 Sep 2019
Hormone-dependent prostate cancer	European Union	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Iceland	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Liechtenstein	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Norway	Janssen-Cilag International NV	14 Jan 2019
Prostatic Cancer	Canada	Janssen Research & Development LLC	27 Jul 2018
Castration-sensitive prostate cancer	Australia	Janssen-Cilag Pty Ltd.	05 Jul 2018
Castration-Resistant Prostatic Cancer	United States	Janssen Biotech, Inc.	14 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	United States	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	China	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Australia	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Brazil	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Canada	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	France	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Germany	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Mexico	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Poland	Janssen Research & Development LLC	31 Aug 2023
Adenocarcinoma of prostate	Phase 3	Hong Kong	Janssen LP	20 Jul 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02489318 (TITAN, ASCO2026)	Phase 3	Advanced Prostate Carcinoma	2,211	Apalutamide+ADT	bzmzzzstap(swavoziwpy) = twjgsyvokp xojxkhqtxn (nieafeljcs ) View more	Positive	29 May 2026
				Placebo+ADT	bzmzzzstap(swavoziwpy) = awqiydvbzq xojxkhqtxn (nieafeljcs ) View more
NCT05884398 (LIBERTAS, ASCO2026)	Phase 3	Metastatic Castration-Sensitive Prostate Carcinoma	118	Apalutamide + continuous androgen deprivation therapy (ADT)	mxnsjzuoik(ujudmydjch) = tpdegvjfxu fscvfyvuia (tdgibamhpz ) View more	Positive	29 May 2026
NCT03767244 (PROTEUS, ASCO2026)	Phase 3	Locally Advanced Prostate Carcinoma	2,109	apalutamide+ADT	lpxmxkvtwg(gutfvyheit) = xqjiqpdnji vykonyslsl (ncrnjawmms ) View more	Positive	29 May 2026
				placebo+ADT	lpxmxkvtwg(gutfvyheit) = tfipzziqby vykonyslsl (ncrnjawmms ) View more
NCT02789878 (NeoPRO, ASCO2026)	Phase 2	Localized Prostate Carcinoma Neoadjuvant	62	goserelin+abiraterone acetate+prednisone	umzkpshhze(aidwexexta) = zsezvbqdqn dlmhkjwfsb (decscoddlu ) View more	Negative	29 May 2026
				goserelin+abiraterone acetate+prednisone+apalutamide	umzkpshhze(aidwexexta) = pzzcekbajp dlmhkjwfsb (decscoddlu ) View more
NCT02772588 (CTgov)	Phase 2	Prostatic Cancer \| Adenocarcinoma of prostate	64	stereotactic, ultra-fractionated radiotherapy+ARN-509+Abiraterone+Leuprolide	azrrkntpmd = mzsfffslao ccmhrxbyyc (dmfvlnibfs, lileqawuzn - fatdlgrqia) View more	-	13 Apr 2026
NCT06013475 (DEAR-EXT, Pubmed \| Prostate Cancer Prostatic Dis)	Not Applicable	Castration-Resistant Prostatic Cancer	1,375	Darolutamide	ubhdsgvnlb(rnyfblkvmy) = dbalbkwdbl qqimiuzolj (bkgwqlenjp ) View more	Positive	18 Mar 2026
				Enzalutamide	ubhdsgvnlb(rnyfblkvmy) = sjmxosvwnp qqimiuzolj (bkgwqlenjp ) View more
ASCO_GU2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma First line	1,274	Enzalutamide	rwaaewxkhc(remphhihaa) = ocbyfxyxdp dzspgzgepj (yzjoydskqy, NE - NE) View more	Positive	26 Feb 2026
				Apalutamide	rwaaewxkhc(remphhihaa) = wusbwmepas dzspgzgepj (yzjoydskqy, NE - NE) View more
CTIS2023-509837-37-00 (INDUCTA, ASCO_GU2026)	Phase 2	Prostatic Cancer	21	Apalutamide 240 mg + Apalutamide 240 mg	bcdtzqakfy(qmhyrcjwme) = qglwdwlnyk ezcxezmten (chwscwklzl ) View more	Positive	26 Feb 2026
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	tivkxhbobo(cfpuypgebg) = acsxzzwyrp tuejkeyckb (nhmysbtuel ) View more	Negative	26 Feb 2026
				Apalutamide	tivkxhbobo(cfpuypgebg) = peskglximw tuejkeyckb (nhmysbtuel ) View more
ASCO_GU2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	859	Apalutamide (APA)	oezxonmjsp(bgrzkybypx) = ixxtulxbhj hjegbwxokk (bgnivybwtq ) View more	Positive	26 Feb 2026
				Darolutamide (DARO)	oezxonmjsp(bgrzkybypx) = ciawqgnkjp hjegbwxokk (bgnivybwtq ) View more

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