On April 24, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that its ultra-sensitive Signatera Genome assay is now broadly available to physicians in the United States (Press release, Natera, APR 24, 2025, View Source [SID1234652122]).

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This launch is supported by a large genome-based molecular residual disease (MRD) study, which was accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In this clinical validation study of more than 3,000 samples from multiple cancer types – including breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma – Signatera Genome was able to detect circulating tumor DNA (ctDNA) significantly ahead of clinical recurrence with excellent performance. In addition, postsurgical Signatera-positive patients had inferior recurrence-free survival compared to Signatera-negative patients, consistently across the different cancers that were evaluated. Additional clinical utility data on the Signatera Genome assay, including predictive data, will be presented at the conference.

Signatera Genome is available in CLIA, IUO and RUO and was designed to improve patient management as an ultra-sensitive assay for the detection of ctDNA. The test’s bespoke assay is designed from a whole genome sequence of a patient’s tumor and matched normal DNA. It benefits from Natera’s patented multiplex polymerase chain reaction and next generation sequencing technology (mPCR-NGS), using a targeted and deep sequencing approach to detect tiny traces of tumor DNA at frequencies as low as 1 part per million (PPM). An RUO version of the assay is available that detects below 1 PPM.

"We are extremely pleased with the emerging evidence for our Signatera Genome assay, providing an ultrasensitive MRD detection tool for physicians," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. "We look forward to sharing the results of this study, which further demonstrates the clinical utility of Signatera across disease indications."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage from Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On April 24, 2025 Novocure (NASDAQ: NVCR) reported financial results for the first quarter ended March 31, 2025. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields) (Press release, NovoCure, APR 24, 2025, View Source [SID1234652121]).

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"This is a period of meaningful momentum for Novocure," said Ashley Cordova, CEO Novocure. "After years in a single commercial indication, our footprint is expanding across new indications, new centers, and new physician specialties. Our lung launch is progressing. Our pipeline is advancing. And our commitment to patient-forward innovation is stronger than ever. We look forward to updating you on our progress as the year unfolds."

Financial updates for the first quarter ended March 31, 2025:

Total net revenues for the quarter were $155.0 million, an increase of 12% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets and to a lesser extent from reimbursement improvements.
The U.S., Germany, France and Japan contributed $93.2 million, $18.7 million, $17.9 million and $8.7 million, respectively, with other active markets contributing $11.9 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the quarter was $1.5 million, including $0.8 million from malignant pleural mesothelioma (MPM), and $0.7 million from metastatic non-small cell lung cancer (NSCLC).
Gross margin for the quarter was 75% compared to 76% in the prior year period.
The reduction of gross margin was primarily driven by the roll out of our HFE arrays and the NSCLC launch, where we are treating on-label patients at risk prior to establishing broad reimbursement.
The global tariff environment is changing rapidly. On April 9, 2025 the U.S. temporarily delayed implementation of new tariffs by 90 days, resulting in a 10% tariff for most countries. If the current pause is extended through year-end, Novocure could see an increase in import duties of up to $8 million in 2025. If the tariffs return to pre-April 9 rates after the current 90-day pause, Novocure could see an increase in import duties of up to $11 million in 2025. Novocure is closely monitoring the evolving tariff landscape with the intent to mitigate impacts on our supply chain costs where possible.
Research, development and clinical studies expenses for the quarter were $53.8 million, an increase of 4% from the same period in 2024.
Sales and marketing expenses for the quarter were $55.8 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force.
General and administrative expenses for the quarter were $44.8 million, an increase of 13% compared to the same period in 2024. This was primarily driven by a $2.3 million one-time expense to retire a production line related to supply chain optimization efforts and higher personnel costs associated with our launch of NSCLC and preparations for additional future indication launches
Net loss for the quarter was $34.3 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $(5.0) million.
Cash, cash equivalents and short-term investments were $929.1 million as of March 31, 2025.
Operational updates for the first quarter ended March 31, 2025:

As of March 31, 2025, there were 4,268 total active patients on TTFields therapy globally.
Optune Gio
1,608 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 908; 198; 207 and 118 prescriptions, respectively, with the remaining 177 prescriptions contributed by other active markets.
As of March 31, 2025, there were 4,162 active Optune Gio patients on therapy, an increase of 9% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,157; 573; 463 and 445 Optune Gio active patients, respectively, with the remaining 524 active patients contributed by other active markets.
Optune Lua
127 total prescriptions for Optune Lua were received in the quarter. 92 Optune Lua prescriptions were received for the treatment of metastatic NSCLC and 35 prescriptions were received for the treatment of malignant pleural mesothelioma (MPM).
As of March 31, 2025, there were 106 active Optune Lua patients on therapy, including 62 patients treated for metastatic NSCLC patients and 44 patients treated for MPM.
Beginning in Q1 2026, Novocure intends to stop reporting new prescriptions received in period and will provide active patients on TTFields therapy by indication and by material market as the key operating statistics.
Quarterly updates and achievements:

In 2024, Novocure announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in overall survival. The results of the Phase 3 PANOVA-3 clinical trial will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) scientific congress. Novocure plans to host an investor event with live webcast featuring the trial principal investigator and Novocure leadership following the presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
In April, Novocure received CE Mark for the use of Optune Lua concurrently with immune checkpoint inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen.
Anticipated clinical milestones:

Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (H1 2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (H1 2026)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2025 financial results at 8:00 a.m. EDT today, Wednesday, April 24, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 24, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a strategic collaboration with Pfizer, Inc. (NYSE: PFE), to support the development and commercialization of Pfizer’s oncology portfolio using the Guardant Infinity smart liquid biopsy platform (Press release, Guardant Health, APR 24, 2025, View Source [SID1234652120]).

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Under the multi-year collaboration agreement, Guardant and Pfizer aim to:

Utilize Guardant’s portfolio of liquid biopsy tests in Pfizer’s global clinical studies
Evaluate the clinical utility of (a) circulating tumor DNA (ctDNA) level as a surrogate endpoint to monitor therapy response and (b) related blood-based epigenomic analyses
The collaboration will also provide Pfizer with access to Guardant’s liquid biopsy tests in China for their global clinical trials that include China cohorts. In July 2022, Guardant announced a strategic partnership with Adicon Holdings Limited, a leading independent clinical laboratory company based in China, to offer Guardant tests to biopharmaceutical companies conducting clinical trials in China. Cancer is the leading cause of death in China, with over three million cancer-related deaths in 2020.

On April 24, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) (Press release, Akeso Biopharma, APR 24, 2025, View Source [SID1234652118]). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.

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This milestone marks penpulimab-kcqx as Akeso’s first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso’s successful entry into the United States regulatory system for the first time. This achievement highlights the company’s innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management.

The FDA’s approval of penpulimab-kcqx validates Akeso’s international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso’s continued clinical development efforts in the global therapeutics markets.

Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US.

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy.

According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx’s FDA approval will expand the number of NPC patients that can benefit from its treatment.

Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China’s innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide."

Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China’s innovative drug development in alignment with international standards."

Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx’s approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso’s focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere."

On April 24, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from May 30 to June 3 (Press release, Kelun, APR 24, 2025, View Source [SID1234652117]). Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper)’s official website on May 22, 2025, local time.

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Detailed information on the studies selected for ASCO (Free ASCO Whitepaper) 2025 are as follows:

Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.
Presentation Type: Oral
Abstract Number: 8507
Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT

Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.
Presentation Type: Oral
Abstract Number: 6004
Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study.
Presentation Type: Rapid oral
Abstract Number: 1019
Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.
Presentation Type: Poster
Abstract Number: 8529
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.
Presentation Type: Poster
Abstract Number: 8615
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer.
Presentation Type: Poster
Abstract Number: 6098
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About KL590586 (A400/EP0031)

A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China.

In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.