On September 24, 2025 Faeth Therapeutics, a clinical-stage biotechnology company developing therapies that target tumor metabolism, reported that results from the investigator-initiated Phase 2 DICE trial (NCT03648489) will be presented as a late-breaking oral session at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin (Press release, Faeth Therapeutics, SEP 24, 2025, View Source [SID1234656209]).

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Title: Mini Oral session: Gynaecological cancers
Location: Cologne Auditorium – CityCube A
Date: Sunday, October 19, 2025
Time: 11:01 am CEST
Presenter: Dr. Jonathan Krell, MD, Ovarian Cancer Action Research Centre at Imperial College London

On September 24, 2025 Lantheus Holdings, Inc. (NASDAQ: LNTH) and GE HealthCare (NASDAQ: GEHC) reported an exclusive licensing agreement for GE HealthCare to develop, manufacture, and commercialize Lantheus’ piflufolastat F18 (PYLARIFY in U.S. market) in Japan for prostate cancer diagnostics and companion diagnostic use. PYLARIFY is used for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

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The agreement includes the transfer of regulatory dossiers, manufacturing competencies and technical support to enable GE HealthCare to drive clinical development in Japan, towards potential regulatory submissions and commercial launch. GE HealthCare will draw on its extensive manufacturing network and R&D expertise following its acquisition in March 2025 of Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan.

Prostate cancer is the fourth most common cancer worldwide, with Japan recording the third highest number of cases in the world in 2022, after the U.S. and China.1

"This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets," said Brian Markison, CEO of Lantheus. "GE HealthCare and NMP’s deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market."

"Bringing targeted PET imaging agents to new geographies supports Lantheus’ Purpose to Find, Fight and Follow disease to deliver better patient outcomes," added Jean-Claude Provost, Chief Science Officer at Lantheus. "By aligning with GE HealthCare, we’re addressing a critical clinical need in Japan, and helping to lay the foundation for a more personalized approach to prostate cancer detection, diagnosis and monitoring."

"This collaboration represents a strategic advancement for GE HealthCare as we expand our pipeline of radiopharmaceuticals and continue to deliver on our commitment to improving patient access to innovative diagnostics," said Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare and President of NMP. "Working alongside Lantheus gives us access to one of the best-in-class PET imaging agents that is already approved in the U.S. and in Europe, and if approved locally, could provide clinicians and their patients with a powerful new option for detecting and monitoring prostate cancer."

Under the terms of the agreement, GE HealthCare will pay Lantheus an upfront license fee, development milestones and tiered royalties based on product sales in Japan. The companies will also establish a Joint Steering Committee to oversee development and commercialization activities.

Piflufolastat F 18 (also known as 18F-DCFPyL, PYLARIFY or PYLCLARI) was FDA-approved in 2021 and is marketed as PYLARIFY. PYLARIFY has made a profound impact on the lives of patients battling prostate cancer and is the number one utilized PSMA PET imaging agent in the U.S. It is a proven diagnostic backed by real-world experience, including in over 500,000 scans across 48 states. In 2023, it was approved in the European Union and is marketed there as PYLCLARI. The European rights were licensed to Curium from Progenics Pharmaceuticals, Inc., a Lantheus company.

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PYLCLARI) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.

PYLARIFY (piflufolastat F 18) Injection in the U.S.

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information

Contraindications
None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, SEP 24, 2025, View Source [SID1234662958])

On September 24, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46-expressing cancer lesions in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, FibroGen, SEP 24, 2025, View Source [SID1234656192]). The trial will also assess the diagnostic and predictive performance of FG-3180, a companion PET imaging agent, which shares the same CD46-targeted antibody used in FG-3246. The ability of FG-3180 to identify mCRPC lesions and predict response to FG-3246 will be evaluated.

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"With the transformation of FibroGen to a U.S.-focused organization now complete and a robust cash runway into 2028, we are excited to advance our FG-3246 program and initiate the Phase 2 monotherapy trial with the activation of the University of California San Francisco (UCSF) site," said Thane Wettig, Chief Executive Officer of FibroGen. "FG-3246 demonstrated compelling clinical activity in patients that were heavily pre-treated, with a competitive radiographic progression free survival benefit in the Phase 1 monotherapy study. We are confident that the dosing regimen of FG-3246, use of prophylactic G-CSF, and the enrollment of patients in earlier lines of treatment of mCRPC set us up to further demonstrate the potential of this program. We anticipate results from the interim analysis of our Phase 2 study in the second half of 2026. We also look forward to reporting the results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in the fourth quarter of this year."

The Phase 2 monotherapy trial (NCT06842498) is a randomized, open label, dose optimization trial designed to evaluate the safety, efficacy, tolerability, and pharmacokinetics (PK) of FG-3246 for the treatment of patients with mCRPC who have progressed following ARSI treatment and who have not received chemotherapy for their mCRPC. The trial is scheduled to enroll 75 patients who will be randomized 1:1:1 to receive either 1.8, 2.4 or 2.7 mg/kg AJBW of FG-3246. The primary endpoint of the trial is the determination of the optimal dose for the Phase 3 trial based on efficacy, safety, and PK parameters. Secondary endpoints include radiographic progression free survival (rPFS), prostate-specific antigen (PSA) 50 response, and PSA90 response. An interim analysis is planned once 12 patients enrolled in each of the three dose arms have completed 12 weeks on study or discontinued and is anticipated in the second half of 2026. An exploratory sub-study will evaluate FG-3180, a companion PET imaging agent, as a diagnostic radiopharmaceutical. All patients deemed eligible for participation in the Phase 2 trial will participate in the sub-study evaluating FG-3180 prior to randomization.

In addition, topline results from the ongoing investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC are expected in the fourth quarter of 2025.

About FG-3246
FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies.

FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC was initiated in the third quarter of 2025, with interim results expected in the second half of 2026. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime. There are about 65,000 drug treatable mCRPC cases in the U.S. annually and 5-year survival in mCRPC is approximately 30%.

On September 24, 2025 Pi Health, a global health technology and clinical research company, reported it will provide fully outsourced clinical research services in a GSK clinical trial with the aim of significantly improving the time and efficiency of the clinical trial process (Press release, GlaxoSmithKline, SEP 24, 2025, View Source [SID1234656210]). Pi Health and GSK have executed a Master Clinical Services Outsourcing Agreement for the collaboration and have begun initial activities for a global Phase 2 oncology clinical trial.

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Pi Health will manage all aspects of this GSK clinical trial through a technology-driven service model, including site selection and activation, patient enrollment, study conduct, real-time monitoring and regulatory submissions.

Pi Health will leverage its Front-end Interoperable Capture System (FICS) platform — integrated with an international network of clinical trial sites across the globe — for the clinical trial. FICS is an end-to-end clinical trial software platform with artificial intelligence capabilities that enriches current systems by using a unified solution that connects sites and sponsors to accelerate trials, enhances compliance, streamlines data flow and automates manual processes.

The FICS platform can make study conduct 50% faster while maintaining audit-ready data quality. Pi Health’s technology and operational workflows are built to achieve regulatory-grade data capture throughout the lifecycle of trials, enabling perpetual, real-time readiness for regulatory reviews and eliminating the need for manual reconciliation and expensive third-party processing.

"By applying Pi Health’s technology and international reach to GSK’s global scale and expertise, we believe we can accelerate the development of vital treatments for patients in need of new therapies by making clinical trials faster and more efficient," said Pi Health CEO and co-founder Geoffrey Kim, M.D., former Deputy Director of the Oncology Center of Excellence at the Food and Drug Administration (FDA). "This collaboration validates our commitment to fundamentally reimagining how trials should be run. Our technology provides the transparency and efficiency that senior leadership demands while delivering the data quality that regulators require."

"We are thrilled about what this agreement represents for global drug development," said Bobby Reddy, M.D., Chief Operating Officer and co-founder of Pi Health. "We are optimistic about collaborating with GSK to support its efforts in streamlining clinical trial delivery, with our shared goal of developing medicines more efficiently for patients."

"Pi Health’s integrated approach to clinical trial management, and its team’s strong background in drug development and regulation, made them a natural choice," said Zeshaan Rasheed, M.D., Ph.D., Senior Vice President, Head of Oncology Clinical Development at GSK. "By removing inefficiencies that can slow progress in clinical trials, Pi Health is well positioned to help us focus on our main priority: getting innovative medicines to people with cancer as quickly and as safely as possible."

Pi Health was founded by physicians and has assembled a multidisciplinary team that includes highly experienced clinicians, principal investigators, former industry leaders with deep experience in pharma and biotech clinical development and operations, and former FDA leaders with extensive approval track records (>100 NDAs, BLAs, PMAs reviewed; >1000 INDs reviewed) — giving the company a unique window into the challenges and solutions needed in clinical research.

On September 24, 2025 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported that following a pre-specified interim efficacy analysis for the Phase 2 FORTE basket study evaluating plixorafenib as a monotherapy in patients with recurrent or progressive BRAF V600-mutated primary central nervous system (CNS) tumors, the Independent Data Monitoring Committee (IDMC) has recommended that the study should continue as planned (Press release, Fore Biotherapeutics, SEP 24, 2025, View Source [SID1234656194]).

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The interim efficacy analysis was conducted by the IDMC and was pre-specified to evaluate plixorafenib at a defined efficacy threshold after the first 25 participants treated in this basket had sufficient data for response assessment, in addition to the IDMC’s ongoing oversight for safety.

"We are very pleased that the BRAF V600 primary CNS basket of the FORTE study has passed the protocol-specified interim analysis supporting that tumor regressions in patients treated with plixorafenib continue to be observed," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "We believe this is an encouraging development for the study, and more importantly, for patients in need of novel treatment options for recurrent primary CNS tumors. The data with this novel BRAF inhibitor, known as a paradox breaker, builds on the recent momentum for the potential of plixorafenib to benefit patients across BRAF-altered solid tumors, including the recent presentation of encouraging data in patients with BRAF-altered thyroid cancers, which has generated significant enthusiasm in the field. This significant milestone builds upon the validated approach of targeting BRAF, while avoiding the limitations of the earlier generation compounds that led to rapid recurrence of disease and the need for combination with a MEK inhibitor, and brings us one step closer to our objective of accelerating access to adults and children diagnosed with recurrent BRAF-altered brain or spinal cord tumors. We look forward to completing enrollment and reporting topline results from this registrational CNS basket in the second half of 2026."

Macarena de la Fuente, M.D., Chief of Neuro-Oncology at the University of Miami Sylvester Comprehensive Cancer Center and lead CNS Investigator for both the Phase 1/2a and FORTE Phase 2 plixorafenib clinical studies, commented, "Primary CNS tumors can lead to significant disease and treatment-related morbidity, including neurocognitive deterioration and seizures, and premature death. The unique mechanism and tolerable safety profile seen in early clinical trials set plixorafenib apart from current limited treatments, including lower side effects of rash or fever and less risk of intratumoral bleeding, cardiac, ocular, or growth effects. The data that have been previously presented are very promising with durable clinical activity and favorable tolerability and we look forward to the full readout of data at the completion of this trial. We anticipate plixorafenib, with its unique mechanism of action, has the potential to transform the treatment paradigm for people with BRAF-altered recurrent or refractory primary CNS tumors."

The primary endpoint of overall response rate (ORR), supported by duration of response, in the FORTE CNS basket is being evaluated in up to 50 patients with BRAF V600 primary recurrent CNS tumors.

About the Global Phase 2 FORTE Basket Study

The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600 primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the design of the trial, interim efficacy analyses will be conducted in the other two baskets of FORTE – the advanced solid tumors with BRAF fusions basket and the rare BRAF V600 solid tumors basket – after sufficient scans from approximately 25 patients in each basket are evaluated by the IDMC.

About BRAF Altered Recurrent Primary CNS Tumors

BRAF altered recurrent primary CNS tumors represent a high unmet medical need and a large market opportunity for plixorafenib. In the advanced treatment setting, patients are offered currently approved therapies, but those therapies have significant limitations in efficacy, tolerability, and safety.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore Bio believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.