On June 4, 2026 Lupeng Pharmaceutical reported that the National Medical Products Administration (NMPA) has granted accelerated approval to rocbrutinib (development code: LP-168) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have received at least two prior systemic therapies, including BTK inhibitors.

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Rocbrutinib, independently developed by Lupeng Pharmaceutical, is the fourth-generation BTK inhibitor with dual covalent (irreversible) and non-covalent (reversible) mechanism. The approval of rocbrutinib will provide a new breakthrough treatment option for R/R MCL patients following failure of earlier-generation BTK inhibitor therapy.

Dr. Tan Fenlai, co-founder and CEO of Lupeng Pharmaceutical, stated, "The successful approval of rocbrutinib is a major milestone in Lupeng Pharmaceutical’s development. It will bring a new and effective treatment option to MCL patients who have experienced disease progression after earlier-generation BTK inhibitor therapy. Furthermore, it demonstrates Lupeng’s global leadership in advancing BTK-targeted innovation. Going forward, we will continue to advance clinical studies of rocbrutinib in other indications such as diffuse large B-cell lymphoma (DLBCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), to help more patients with various hematologic malignancies."

Dr. Chen Yi, co-founder and CSO of the company, said, "The market launch of rocbrutinib is a successful example of Lupeng’s ‘innovation methodology,’ proving that the company’s unique ‘Beyond the Rule of 5’ , BeyondX Oral MedChem Platform , can efficiently develop next-generation, globally best-in-class small molecule targeted drugs featuring novel mechanisms of action."

The NMPA approval of rocbrutinib for the treatment of R/R MCL is primarily based on positive results from a nationwide, multi-center, open-label, single-arm Phase II registration clinical trial (the ROCK-1 study)[1-2], led by Professor Zhu Jun and Professor Song Yuqin from Peking University Cancer Hospital. Forty-one centers across China participated in the study, which was designed to evaluate the efficacy and safety of rocbrutinib monotherapy in MCL patients who had relapsed or were refractory after prior treatment with covalent BTK inhibitors. As of June 5, 2025, clinical trial data showed an objective response rate (ORR) of 63.9%, a complete response rate (CR) of 23%, and a median duration of response (mDOR) of 16.5 months. All enrolled patients had previously received at least a covalent BTK inhibitor; more than one-third of them had received two or more cBTK inhibitors. Baseline characteristics of the patient group were generally difficult to treat and had poor prognosis. In terms of safety, no atrial fibrillation/flutter or other cardiac events occurred, and no patient permanently discontinued treatment due to adverse events. The incidence of BTK inhibitor–associated toxicity was relatively low.

In April 2026, rocbrutinib was included for the first time in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Lymphoma , where it was listed as a Category II recommendation for the treatment of R/R MCL. Its inclusion in the guidelines prior to formal NMPA approval reflects the recognition by leading clinical experts of rocbrutinib’s innovative mechanism and promising clinical value in addressing the significant unmet need in R/R MCL.

Professor Weiping Liu of Peking University Cancer Hospital noted that, based on key evidence from clinical studies, rocbrutinib has become an important recommended treatment option for MCL and provides support for standardized clinical practice. Professor Jun Ma of Harbin Institute of Hematology & Oncology further emphasized that patients with R/R MCL have long lacked effective standard treatment options, representing a major challenge in clinical practice. As the first fourth-generation BTK inhibitor to reach the marketing application stage, rocbrutinib’s dual covalent and non-covalent mechanism enables it to target C481-site and other resistance mutations such as T474I and L528W, providing a scientific basis for overcoming acquired resistance.

The recommendation provides authoritative and standardized clinical guidance for physicians and offers a new treatment opportunity for patients with R/R MCL.

More importantly, rocbrutinib’s anti-tumor activity is not limited to MCL; it has demonstrated positive therapeutic potential in various B-cell malignancies, including DLBCL, CLL/SLL and Marginal zone lymphoma (MZL). The guidelines also include a note indicating rocbrutinib’s efficacy as monotherapy or in combination therapy for patients with R/R DLBCL.

Based on preliminary study results in adult patients with non-GCB DLBCL who had received at least two prior lines of treatment, rocbrutinib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) in May 2024. The corresponding pivotal Phase II registration study (ROCK-2) had already been initiated by the end of 2025.

Results from a Phase I study conducted in the United States showed that rocbrutinib achieved an ORR of 78.3% at doses of 200–300 mg/day in CLL patients previously treated with BTK inhibitors, with an estimated median progression-free survival (PFS) of 28.1 months in the 100–300 mg/day dose range[3]. In January 2026, the global Phase III head-to-head clinical trial comparing rocbrutinib with the third-generation non-covalent BTK inhibitor pirtobrutinib for the treatment of R/R CLL/SLL (the ROCKET-CLL study, NCT07342478) was launched, marking a new stage in rocbrutinib’s global development.

(Press release, Guangzhou Lupeng Pharmaceutical, JUN 4, 2026, View Source [SID1234666448])

On June 4, 2026 Rami Owera, MD, medical oncologist and hematologist with Woodlands Specialty Physicians, a division of Florida Cancer Specialists & Research Institute reported an abstract detailing findings from the MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) Consortium Protocol 2, a prospective real-world study examining patterns in biomarker testing, treatment decision-making, and the barriers and workflows that shape care for patients with lung cancer in community settings.

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The study, published in the Journal of Clinical Oncology, provides early insights into how patients with newly diagnosed non-small cell lung cancer (NSCLC) are tested and treated in community oncology settings.

"We’re seeing meaningful progress in biomarker testing for lung cancer, particularly in the use of more comprehensive genomic profiling," said Dr. Owera. "At the same time, gaps remain in ensuring all patients receive complete results before starting treatment—an essential step in delivering truly personalized care—underscoring opportunities to strengthen workflows, access and lung cancer care overall."

FCS President & Managing Physician Lucio N. Gordan, MD said, "These findings confirm the critical importance of FCS’ ongoing expansion of genomic testing capabilities to ensure patients consistently receive the right test at the right time and fully realize the benefits of precision oncology."

The study, which aims to track up to 12,000 patients, is part of the broader MYLUNG Consortium initiative engaging leading oncology practices, researchers and industry partners to generate real-world evidence and identify strategies to enhance personalized care delivery and improve outcomes for patients with lung cancer. Dr. Owera noted that MYLUNG Protocol 3 will continue to explore interventions that have demonstrated promise in enhancing effectiveness in biomarker testing.

Dr. Owera is actively involved in clinical research as a principal investigator and sub-investigator in collaboration with the Sarah Cannon Research Institute. His research has included numerous clinical trials across a wide range of malignancies, including breast, lung, gastrointestinal and hematologic cancers.

(Press release, Florida Cancer Specialists & Research Institute, JUN 4, 2026, View Source;research-institute-real-world-evidence-abstract-highlights-progress-and-gaps-in-biomarker-testing-for-lung-cancer-302791597.html [SID1234666449])

On June 4, 2026 Onchilles Pharma, a clinical-stage biotechnology company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported that the first patient has been dosed in its Phase 1/2 clinical trial evaluating N17350 in patients with advanced solid tumors. N17350, Onchilles’ lead tumor-directed therapeutic candidate, is designed to selectively kill cancer cells, while preserving immune cells, and to stimulate systemic anti-tumor immunity.

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"Dosing the first patient with N17350 marks a major step forward for Onchilles as we move from years of translational research into clinical evaluation," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles Pharma. "N17350 was developed to address a central challenge in cancer treatment: how to directly kill tumor cells while preserving and activating the immune system. This Phase 1/2 study gives us the opportunity to evaluate whether the broad, selective, immune-activating activity we have observed preclinically can translate into benefit for patients with advanced solid tumors."

N17350 is designed to leverage the ELANE pathway, a cancer-selective mechanism that induces immunogenic cancer cell death while sparing healthy tissue, including immune cells. In preclinical studies, N17350 demonstrated broad tumor-killing activity, immune cell preservation, and activation of anti-tumor immunity across multiple solid tumor models. The open-label, dose-finding and expansion study is designed to evaluate the safety, tolerability, recommended dose, anti-tumor activity, and biomarker effects of intratumorally administered N17350 in patients with advanced solid tumors.

"Patients with advanced solid tumors need new therapeutic approaches that can produce direct anti-tumor activity while potentiating, rather than compromising, anti-tumor immunity," said Matteo Carlino, M.D., PhD, investigator in the Phase 1/2 study, Westmead Hospital, Sydney, Australia. "N17350 is based on a novel biological rationale, and this first-in-human study is an important step in evaluating its safety, dose, activity, and immune effects in patients."

The Phase 1/2 study will initially evaluate N17350 in patients with advanced solid tumors accessible for intratumoral administration, with planned assessments of safety, dose escalation, anti-tumor activity, and translational biomarkers. Onchilles expects the study to support clinical evaluation of N17350 as both a monotherapy and, over time, as part of rational combination strategies with immunotherapy.

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages altered histone H1 biology, a vulnerability shared by many cancer cell types. Our pipeline is led by N17350, our first-in-class, clinical-stage program, followed by NEU-002, the second program that extends this approach with systemic delivery. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential gamechangers in cancer therapy.

(Press release, Onchilles Pharma, JUN 4, 2026, View Source [SID1234666450])

On June 4, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, reported a strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics and generate real-world molecular insights to support CytoDyn’s metastatic colorectal cancer (mCRC) development program.

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Under the agreement, Natera will assess CytoDyn clinical trial samples from the CLOVER Phase 2 study (ClinicalTrials.gov Identifier: NCT06699836) in patients with mCRC. SignateraTM, Natera’s personalized assay for the detection of molecular residual disease (MRD), will be used to evaluate ctDNA dynamics and molecular response patterns associated with leronlimab treatment.

Natera will also provide customized real-world data (RWD) analyses leveraging its proprietary oncology database, which is the largest multi-timepoint early- and late-stage oncology dataset with more than 2 million plasma timepoints and enriched clinical and imaging records. By integrating molecular response data from its MRD testing platform with curated electronic medical record (EMR) data, this multimodal dataset enables analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across diverse clinical settings. Together, these capabilities are expected to generate insights into molecular response and disease progression that may help inform future clinical development of leronlimab, including clinical trial design, biomarker-driven patient selection strategies, and broader translational research efforts.

The collaboration builds on CytoDyn’s growing oncology program and follows completion of enrollment in the CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with previously treated mCRC. The collaboration is also expected to complement ongoing translational and biomarker analyses from the study aimed at further characterizing treatment response and informing future development strategies.

"Signatera has become an increasingly important tool in precision oncology and clinical development," said Jacob Lalezari, M.D., chief executive officer, CytoDyn. "Through this collaboration, we expect to gain valuable insights into ctDNA response kinetics and disease progression that may help guide future development strategies for leronlimab in colorectal cancer and potentially other solid tumor indications."

"We are pleased to partner with CytoDyn and provide their team with insights derived from one of the largest and most comprehensive real-world molecular oncology data platforms," said Matt Love, vice president, biopharma data & AI partnering, Natera. "Our platform enables biopharma partners to better understand disease biology, treatment response, and patient outcomes, helping inform key development decisions throughout the drug development lifecycle."

(Press release, CytoDyn, JUN 4, 2026, View Source [SID1234666451])

On June 4, 2026 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported the clinical availability of the ArteraAI Prostate Test (mHSPC), the first digital pathology–based prognostic test designed to help inform treatment planning for patients with metastatic hormone‑sensitive prostate cancer (mHSPC).

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mHSPC is a diverse disease state with widely variable outcomes, requiring complex treatment decisions that can significantly impact both survival and quality of life. While traditional clinical factors provide general prognostic insight, they do not offer individualized risk. The ArteraAI Prostate Test (mHSPC) addresses this gap by delivering a patient‑specific estimate of 5‑year prostate cancer–specific mortality (PCSM) in patients treated with androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI).

"Artera’s platform was built to bring greater clarity to cancer treatment decisions," said Andre Esteva, CEO of Artera. "With our expansion into metastatic hormone-sensitive prostate cancer, we are excited to leverage our validated MMAI approach for a more complex stage of disease, helping guide treatment decisions with greater confidence."

The ArteraAI Prostate Test (mHSPC) builds on Artera’s established biopsy‑based MMAI model used in localized prostate cancer and was further validated in patients with mHSPC receiving ADT plus ARPI as significantly prognostic for prostate cancer–specific mortality.

"As treatment options for metastatic hormone-sensitive prostate cancer have evolved, tools to accurately assess individual patient risk in the context of modern combination therapy have not fully evolved alongside them," said Calvin Chao, MD, PhD, Vice President of Medical Science at Artera. "This clinically validated test is poised to help clinicians better tailor treatment intensity and duration to the individual patient."

The ArteraAI Prostate Test (mHSPC) is available through Artera and its commercial partner, Tempus, supporting broad and convenient access within existing clinical workflows.

(Press release, Artera, JUN 4, 2026, View Source [SID1234666452])