On December 11, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed molecular residual disease (MRD) testing in stage I to III non-small cell lung cancer (NSCLC).

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The study, led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL) in collaboration with Personalis, analyzed 431 NSCLC patients tracked for a median of > 5 years using the NeXT Personal test. It demonstrated that the NeXT Personal test allows for highly sensitive detection of small traces of circulating tumor DNA (ctDNA) in blood samples from lung cancer diagnosis through to surveillance, even in hard-to-detect subtypes.

Key Findings:

Comprehensive Cancer Detection From Diagnosis Through Surveillance: NeXT Personal demonstrated exceptional sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course at diagnosis (pre-surgery), post-surgical (landmark), during adjuvant, and during long-term surveillance monitoring, with many of the detections (~36-43%) in the ultrasensitive range.
Cancer Detection Ahead of Imaging: Cancer was detected a median of ~5 to ~9 months and up to ~57 months ahead of standard of care imaging post-surgery and during surveillance.
Ultrasensitive Detection and Risk Stratification: The study demonstrated NeXT Personal detection of ctDNA pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival. The study also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that can benefit from close clinical follow-up.
Therapy Monitoring: Patients who did not clear their ctDNA during adjuvant chemotherapy were > 5 times more likely to relapse than those who cleared their ctDNA.
The study utilized Personalis’ NeXT Personal technology, which leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to ~1 PPM. The Cell publication highlights that a significant portion of relapsing patients presented with ctDNA levels in the ultrasensitive range, detections which can be missed with less sensitive tests.

"This latest TRACERx study underscores the critical role of ultrasensitive ctDNA monitoring in early-stage lung cancer," said Professor Charles Swanton, Director of the Cancer Research UK Lung Cancer Centre of Excellence and Chief Clinician at Cancer Research UK. "The ability to detect residual disease at extremely low levels allows us to detect traces of cancer earlier after surgical resection in the adjuvant setting and more effectively identify patients at risk for relapse. It also allows us to see how patients are responding to adjuvant therapy with more accuracy, paving the way for more personalized, data-driven treatment strategies."

Richard Chen, M.D., Chief Medical Officer and Executive VP of R&D at Personalis, added: "This publication in Cell confirms that NeXT Personal’s high test-sensitivity and specificity are not just technical specifications, they are key to unlocking clinical utility. By pioneering ultrasensitive MRD testing, we are leading the way in enabling the next generation of cancer care and giving physicians the tools they need to better guide treatment decisions throughout the patient journey."

This publication joins a list of other leading publications this year in Nature Medicine and Annals of Oncology for NeXT Personal, showing the importance of ultrasensitive MRD testing in lung cancer and other cancer types.

(Press release, Personalis, DEC 11, 2025, View Source [SID1234661387])

On December 11, 2025 Innovent Biologics (SSE: 688428; HKSE: 09969), a high-tech biopharmaceutical company, reported that its independently developed next-generation TRK inhibitor, Enoxin ( zolectretinib, ICP-723), has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult and adolescent patients aged 12 years and older with solid tumors harboring NTRK fusion genes. This marks the approval of China’s first independently developed next-generation TRK inhibitor for market launch.

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In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated excellent efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. Registry results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.

As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers great convenience to patients.

Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center stated, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated remarkable efficacy, especially in adolescent patients where the overall response rate (ORR) reached 100% . Clinically, zolectratinib’s onset of action is significantly faster than traditional chemotherapy, with many patients observing significant tumor shrinkage within one to two cycles, providing a valuable treatment window for critically ill patients. Furthermore, the duration of zolectratinib’s effective response is long; the longest response we have observed clinically has exceeded 36 months, offering hope for longer survival to patients with solid tumors."

Professor Luo Zhiguo of Fudan University Cancer Hospital stated, "Most of the patients enrolled in our center are sarcoma patients. Zoletratinib achieved an overall response rate (ORR) of 89.5% in patients with soft tissue sarcoma , demonstrating excellent efficacy. Furthermore, its high selectivity significantly reduces off-target toxicity and exhibits good safety, allowing patients to use the medication long-term without affecting their quality of life. For patients with solid tumors requiring long-term treatment, the efficacy and safety advantages of zoletratinib can help them live longer and better."

Professor Wang Qiming of Henan Cancer Hospital emphasized, "Zoletratinib also demonstrates excellent efficacy in NTRK fusion-positive lung cancer patients, with an overall response rate (ORR) of 88.9%, bringing more hope to lung cancer patients. Simultaneously, zolectratinib exhibits remarkable brain-penetrating activity, achieving a 100% intracranial objective response rate (IC-ORR) and a 100% 12-month intracranial sustained response rate (IC-DOR), achieving strong control of brain lesions. From a molecular mechanism perspective, zolectratinib’s unique structure enables it to penetrate the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing a new treatment option for patients with brain metastases."

Professor Chen Libo of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University stated, " The overall response rate (ORR) for thyroid cancer patients enrolled with zoletrinib was 100% . Patients enrolled in our center have maintained continuous remission for two years, demonstrating the superior efficacy of zoletrinib compared to first-generation TRK inhibitors. Furthermore, as a new generation TRK inhibitor, zoletrinib offers new hope for resistant patients. With its excellent efficacy and good tolerability, zoletrinib can provide long-term, sustained, deep remission for patients with NTRK fusion-positive solid tumors."

Dr. Cui Jisong, co-founder, chairman, and CEO of InnoCare Pharma, said, "Zoletratinib is InnoCare Pharma’s third approved innovative drug and our first approved innovative drug in the field of solid tumors. As a broad-spectrum anticancer drug that is not limited to any type of tumor, zoletratinib has significant clinical implications for patients with NTRK fusion-positive solid tumors. We would like to express our special thanks to the doctors, patients, partners, and employees who participated in this clinical trial for their support, and also to the regulatory agencies for their professional and efficient approval process, which allows more patients with solid tumors to receive better treatment earlier. We believe that zoletratinib, as the first independently developed and approved TRK inhibitor in China, will bring new hope to patients with solid tumors in China."

Zolectretinib has been included in the "Pilot Program for Encouraging the Development of Pediatric Anti-tumor Drugs (Starlight Program)" by the China National Medical Products Administration. Innovent Biologics expects to submit an NDA application for zolectretinib for the treatment of pediatric patients (aged 2 to 12) soon.

NTRK fusion genes are present in various types of tumors and have been found in more than 26 types of solid tumors [1] . It is estimated that there are 6,500 new cases of tumors carrying NTRK fusion genes in China each year. These patients have short survival, rapid disease progression and high disability rate. However, due to the low popularity of the current gold standard detection method – next-generation sequencing (NGS), diagnosis is delayed, so there is still an unmet clinical need. The emergence of the broad-spectrum anticancer drug zoletrinib has brought new treatment options to patients.

(Press release, InnoCare Pharma, DEC 11, 2025, View Source [SID1234663149]).

On December 11, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the first clinical study results from its Oncodetect molecular residual disease (MRD) test in breast cancer. Findings from the NSABP B-59 substudy, conducted in collaboration with the NSABP Foundation and the German Breast Group (GBG), demonstrated that the Oncodetect test strongly predicts distant recurrence following surgery in patients with early triple-negative breast cancer (TNBC)2, one of the most aggressive and difficult-to-treat breast cancer subtypes.3

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These data, representing one of the largest TNBC MRD datasets analyzed to date,1 were presented by Dr. Marija Balic, MD, PhD, scientific director of the NSABP Translational Research Program, at the San Antonio Breast Cancer Symposium (SABCS). The results demonstrate Oncodetect’s ability to help identify patients at higher risk of recurrence and strengthen the growing clinical evidence supporting the test’s role in guiding post-surgical treatment decisions.

The entities intend to submit these data to a peer-reviewed journal for publication, and Exact Sciences will submit the data to MolDx in support of Medicare coverage.

Prognostic performance of the Oncodetect test in early triple-negative breast cancer

In an analysis of 147 patients from the B-59 substudy, post-surgical detection of circulating tumor DNA (ctDNA) was strongly associated with risk of distant recurrence.2 Patients who remained ctDNA-positive after neoadjuvant therapy and surgery had substantially higher recurrence risk compared to ctDNA-negative patients.2 The key findings include:

Post-surgery MRD-positive status was associated with a ~30-fold higher risk of distant recurrence compared to those who were MRD-negative. 2
95% of patients who were MRD negative after surgery remained free of distant recurrence at 3 years. 2
Neo-adjuvant therapy given before surgical resection, which is the standard of care in patients with TNBC, reduced ctDNA positivity in patients from 95% before the start of treatment to 9% after treatment. 2
These data demonstrate that ctDNA detection after surgery is a powerful prognostic indicator of recurrence risk in TNBC and may help identify patients who could benefit from additional adjuvant therapy.

"The NSABP Foundation is proud to collaborate on this impactful study," said Dr. Norman Wolmark, chairman, NSABP Foundation. "The strength of these data, particularly the clear separation in distant recurrence curves, highlight the prognostic power of ctDNA and its potential to guide post-surgical management strategies for high-risk breast cancer."

Inside the NSABP B-59 study

In partnership with the NSABP Foundation, the Oncodetect substudy was conducted within the NSABP-B-59/GBG-96-GeparDouze trial, which enrolled patients with TNBC receiving neoadjuvant therapy with or without atezolizumab. Blood samples were collected before treatment and after surgery to evaluate whether ctDNA positivity at the post-surgery timepoint was associated with distant recurrence-free interval, with a median follow-up of 37 months. Exact Sciences is also collaborating with the NSABP Foundation on NSABP B-64, a large prospective registry trial enrolling 1,800 participants across all breast cancer subtypes.

"This is an important milestone for our Oncodetect program and for patients facing aggressive breast cancers like TNBC," said Dr. Rick Baehner, senior vice president, chief medical officer, Precision Oncology at Exact Sciences. "These data demonstrate how ctDNA testing can provide critical insights into recurrence risk and more precisely help inform treatment decisions."

(Press release, Exact Sciences, DEC 11, 2025, View Source [SID1234661371])

On December 11, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) being held December 9-12, 2025, in San Antonio, TX. NKT5097 is a first-in-class, orally bioavailable small molecule engineered to selectively degrade CDK2 and CDK4 simultaneously, offering potential therapeutic benefits for patients with HR+ breast cancer and tumors driven by aberrant CDK2/cyclin E pathway activation.

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NiKang has initiated a Phase 1, open-label, dose escalation study of NKT5097 as a single agent. This first-in-human study (NCT07029399) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification.

"We are excited to share these compelling preclinical data for NKT5097 at this year’s SABCS," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "Our research has centered on designing a molecule that selectively degrades CDK2 and CDK4 while sparing CDK1, CDK6, CDK7, and CDK9, with the goal of significantly reducing the gastrointestinal and hematologic toxicities associated with currently approved CDK4/6 inhibitors and addressing emerging resistance mechanism. NKT5097 represents the first compound from our industry-leading CDK2/4 degrader portfolio. Its unique ability to simultaneously degrade both CDK2 and CDK4 offers a promising therapeutic strategy that may deliver deeper and more durable clinical benefits for patients."

Poster Presentation Details:

Title:

Discovery of NKT5097: a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader for cancer therapy

Presenter:

Ke Liu

Abstract Number:

847

Presentation Number:

PS4-04-30

Date and Time:

Thursday, December 11, 2025, 5:00 PM – 6:30 PM

About NKT5097

NKT5097 is a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader, designed to achieve sustained inhibition of the CDK2 and CDK4 pathway. By maximizing selective suppression of these pathways, NKT5097 has the potential to harness the full therapeutic benefits of CDK2 and CDK4 inhibition. NKT5097 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT07029399).

(Press release, NiKang Therapeutics, DEC 11, 2025, View Source [SID1234661388])

On December 11, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported a strategic restructuring plan intended to position the Company for long-term value creation for patients and shareholders and improve its financial discipline.

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"After my first four months at Geron, the leadership team and I have assessed the business with the goal of streamlining our organizational structure to advance our strategy and create long-term value. We are implementing these changes from a position of strength and in the spirit of prudent fiscal management," said Harout Semerjian, President and Chief Executive Officer of Geron. "Our key objectives remain unchanged. We are focused on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance our Phase 3 IMpactMF trial. We expect this restructuring will have a meaningful impact on our 2026 operating expenses and position Geron to meet the needs of patients. I want to express my gratitude to the employees that will be impacted in this restructuring. Your contributions over the years have made a positive difference in the lives of the people we endeavor each day to assist."

The Company’s strategic restructuring plan is expected to result in an approximately one-third reduction in Geron’s current workforce of approximately 260 employees. As a result of the restructuring plan, which is expected to be substantially complete in the first quarter of 2026, initial projected full year 2026 operating expenses are expected to be less than the Company’s projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026. Geron will incur restructuring charges consisting primarily of cash-based expenses in connection with the restructuring plan, with additional information to be provided in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission. Geron thanks all employees who will be impacted by today’s announcement for their contributions to the Company.

(Press release, Geron, DEC 11, 2025, View Source [SID1234661372])