IceCure’s Cryoablation System Combined with Radiation Therapy Successfully Treats Non-Small Cell Lung Cancer (NSCLC) with 92% Disease-Specific 5-year Survival

On November 3, 2025 IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported the publication of an independent study using IceCure’s Cryoablation System titled "Long-term outcomes of combination therapy with stereotactic body radiation therapy plus cryoablation using liquid nitrogen for stage I non-small cell lung cancer with tumors ≥2 cm" in the peer-reviewed journal PLOS One. The study was led by Dr. Hiroaki Nomori of the Department of Thoracic Surgery, Kashiwa Kousei General Hospital, Japan, along with researchers from Tokyo University Hospital, Kashiwa Kousei General Hospital, and Sonodakai Radiation Clinic, Tokyo.

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"While radiation therapy is the standard of care for inoperable stage I NSCLC patients, using SBRT alone unfortunately results in far lower overall survival and lower local control than surgery in certain patients. This study, which focused on people with relatively larger tumors, indicative of later stage disease, provides very encouraging results confirming that combining SBRT with our cryoablation system offers inoperable patients longer life expectancy and may also provide a minimally invasive option to surgery for the broader population of stage I NSCLC patients," stated IceCure’s Chief Executive Officer, Eyal Shamir. "The results of this study may be highly impactful in our major markets including the U.S. and Europe."

The objective of the independent retrospective observational study was to evaluate the effectiveness of combining SBRT with cryoablation for treating stage I NSCLC tumors ≥2 cm, given the limitations of local control and survival rates with SBRT monotherapy. 64 patients with tumors of mean diameter of 2.7 ± 0.5 cm and a range of 2.0–4.0 cm were treated with SBRT, followed by cryoablation. The median follow-up duration was 74 months, with a range of 3-111 months.

Results include the following:

5-Year Local Control Rate: 93%
5-Year OS Rate: 74% compared to published studies which reported 5-year OS rates of 41% – 52% after SBRT alone for stage I NSCLC, including tumors <2 cm; while surgery, the standard treatment for stage I (IA and IB) NSCLC, has a 5-year OS of 67% – 82% according to published studies
3-Year Disease-specific survival: 96%
5-Year Disease-specific survival: 92%
Treatment-Related Mortality: None
Most frequent complications post-cryoablation: pneumothorax, CTCAE grade 2, 40%
The results of this study align with prior findings from independent studies, including a prior study by Nomuri et al. which reported a recurrence-free rate of 67% – 100% in lung cancer patients treated with IceCure’s cryoablation system.

According to a study published in the CA: A Cancer Journal for Clinicians, the flagship journal of the American Cancer Society, lung cancer was the most frequently diagnosed cancer in 2022, responsible for almost 2.5 million new cases, or one in eight cancers worldwide (12.4% of all cancers) followed by breast cancer (11.6% of all cancers globally).

About ProSense

ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of early-stage, low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on our website.

ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.

(Press release, IceCure Medical, NOV 3, 2025, View Source [SID1234659303])

Akeso’s Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

On November 2, 2025 Akeso (9926.HK) reported that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).

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The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:

Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China’s National Reimbursement Drug List.

First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.

Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab’s substantial clinical benefit across multiple major cancer types and reinforces Akeso’s commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.

(Press release, Akeso Biopharma, NOV 2, 2025, View Source [SID1234659227])

OncoHost to Present Two Posters Highlighting Advances in Plasma Proteomics Monitoring and Prediction for NSCLC at ISLB 2025

On November 2, 2025 OncoHost, a global leader in precision oncology and proteomics-based biomarker development, reported the presentation of two new research posters at the 2025 International Society for Liquid Biopsy (ISLB) Annual Congress. The studies underscore the transformative potential of plasma proteomics in improving clinical decision-making and real-time disease monitoring for patients with non-small cell lung cancer (NSCLC).

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Poster 1: Plasma Proteomics as a Systemic Monitoring Approach in NSCLC Immunotherapy: Comparative Analysis with ctDNA

Presenter: Michal Harel, Ph.D., VP Translational Medicine, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

This study introduces a comparative analysis between plasma proteomic signatures and circulating tumor DNA (ctDNA) to evaluate immunotherapy response in advanced NSCLC.

Leveraging aptamer-based proteomic profiling of approximately 7,000 plasma proteins per sample, researchers identified three key proteomic signatures reflecting:

Soluble PD-1/PD-L1 drug bioavailability,
T-cell activation and immune engagement, and
Intracellular proteins indicating lung tissue damage.
Notably, the tissue-damage signature enabled early detection of non-responders up to 6.6 months before standard imaging. While ctDNA tumor load correlated modestly with this signature, only the proteomic analysis effectively distinguished clinical response groups.

"These results demonstrate the unique systemic insight offered by plasma proteomics – capturing the full tumor-immune interaction beyond what is achievable with ctDNA alone," said Dr. Harel. "This approach has the potential to revolutionize real-time treatment monitoring for immunotherapy patients."

Poster 2: A Plasma Proteomics Test Predicts Immunotherapy Benefit in NSCLC Independent of Genomic Alterations

Presenter: Anna Manasherov, MSN-FNP, MPH, Director, Scientific Affairs, OncoHost
Presentation Time: Sunday, November 2, 10:45–11:45, Tuesday, November 3, 9:00-10:00

The second study evaluated the performance of PROphetNSCLC, OncoHost’s commercially available liquid biopsy proteomics test, in predicting immunotherapy benefit across major genomic subgroups.

Analyzing pre-treatment plasma samples from 308 NSCLC patients treated with immune checkpoint inhibitors, the study revealed that a PROphet-POSITIVE result predicted significantly longer overall survival (HR=0.39, p<0.0001) – a benefit consistently observed across KRAS, STK11, TP53, and KEAP1 mutation subgroups.

Importantly, the predictive power of PROphetNSCLC was maintained independent of mutational status and PD-L1 expression, establishing it as a universal biomarker for immunotherapy benefit prediction.

"The data reinforce the value of PROphetNSCLC as an independent, mutation-agnostic tool supporting oncologists in selecting optimal first-line treatments," said Ofer Sharon, MD, CEO at OncoHost. "Our findings highlight the power of proteomics to transcend genomic boundaries and provide actionable clinical insights."

(Press release, OncoHost, NOV 2, 2025, View Source [SID1234659228])

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

On November 2, 2025 Samsung Epis Holdings Co., Ltd. reported its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS). Samsung Epis Holdings will be listed on Korea Exchange (KRX) on November 24, 2025, after establishment of a new subsidiary company on November 14, 2025. Samsung Bioepis will continue to operate its biosimilar business as a 100% owned subsidiary of Samsung Epis Holdings.

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Kyung-Ah Kim will serve as the President and Chief Executive Officer (CEO) of Samsung Epis Holdings, in addition to her current role as the President and CEO of Samsung Bioepis. "The new investment holding company will focus on discovering and securing investment opportunities in biotechnology for the company and its subsidiaries’ long-term growth, with scientific innovation remaining the source of our value creation. In the meantime, Samsung Bioepis will remain committed to ensuring the continued development, manufacturing, and distribution of quality-assured biosimilar medicines to patients around the world," said Kyung-Ah Kim, President and CEO of Samsung Epis Holdings. "By establishing an independent decision-making structure, we see the potential for further growth and investment. Progress is being made to secure next-generation therapeutic technology on the back of the capabilities accumulated through our biosimilar business. With the spin-off, we expect to have more opportunities to explore next-generation growth drivers."

(Press release, Samsung Epis Holdings, NOV 2, 2025, View Source [SID1234659229])

AbbVie Reports Third-Quarter 2025 Financial Results

On October 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the third quarter ended September 30, 2025.

"AbbVie continues to deliver outstanding results, with significant momentum across key areas of our portfolio. We are also making great progress advancing our pipeline and investing in innovation to support AbbVie’s long-term growth," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based upon the strength of our business and its promising outlook, we are once again raising our quarterly cash dividend."

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Third-Quarter Results

•Worldwide net revenues were $15.776 billion, an increase of 9.1 percent on a reported basis, or 8.4 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.885 billion, an increase of 11.9 percent on a reported basis, or 11.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.708 billion, an increase of 46.8 percent on a reported basis, or 46.0 percent on an operational basis.
◦Global Rinvoq net revenues were $2.184 billion, an increase of 35.3 percent on a reported basis, or 34.1 percent on an operational basis.
◦Global Humira net revenues were $993 million, a decrease of 55.4 percent on a reported basis, or 55.7 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.841 billion, an increase of 20.2 percent on a reported basis, or 19.6 percent on an operational basis.
◦Global Vraylar net revenues were $934 million, an increase of 6.7 percent.
◦Global Botox Therapeutic net revenues were $985 million, an increase of 16.1 percent on a reported basis, or 15.8 percent on an operational basis.
◦Global Ubrelvy net revenues were $354 million, an increase of 31.5 percent.
◦Global Qulipta net revenues were $288 million, an increase of 64.1 percent on a reported basis, or 63.1 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.682 billion, a decrease of 0.3 percent on a reported basis, or 1.3 percent on an operational basis.
◦Global Imbruvica net revenues were $706 million, a decrease of 14.8 percent.
◦Global Venclexta net revenues were $726 million, an increase of 7.1 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Elahere net revenues were $170 million, an increase of 23.3 percent on a reported basis, or 22.4 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.193 billion, a decrease of 3.7 percent on a reported basis, or 4.2 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $637 million, a decrease of 4.9 percent on a reported basis, or 5.4 percent on an operational basis.
◦Global Juvederm net revenues were $253 million, a decrease of 2.2 percent on a reported basis, or 3.2 percent on an operational basis.

•On a GAAP basis, gross margin in the third quarter was 66.4 percent. The adjusted gross margin was 83.9 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 22.6 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 14.7 percent of net revenues. The adjusted R&D expense was 14.3 percent of net revenues.

•Acquired IPR&D and milestones expense was 17.0 percent of net revenues.

•On a GAAP basis, operating margin in the third quarter was 12.1 percent. The adjusted operating margin was 30.9 percent.

•Net interest expense was $667 million.

•On a GAAP basis, the tax rate in the quarter was 73.7 percent. The adjusted tax rate was 24.5 percent.

•Diluted earnings per share (EPS) in the third quarter was $0.10 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $1.86. These results include an unfavorable impact of $1.50 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA) that updates the indication statement for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn’s disease (CD). The updated indication statement allows the use of Rinvoq prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy.

•AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 45.2% and 55.0% of patients with severe AA treated with Rinvoq 15 mg and 30 mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤ 20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤ 10) and complete scalp hair coverage (SALT=0) at week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie announced topline results from two replicate Phase 3 studies evaluating the efficacy and safety of Rinvoq 15 mg in adult and adolescent patients living with non-segmental vitiligo (NSV). In the studies, Rinvoq achieved the co-primary endpoints of 50% reduction in total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48. Additionally, across both studies, statistically significant differences were observed with Rinvoq versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48. The safety profile of Rinvoq in both studies was generally consistent with that observed in approved indications.

•AbbVie announced positive topline results from the Phase 3b/4 head-to-head SELECT-SWITCH study evaluating the efficacy and safety of Rinvoq compared to Humira (adalimumab) in adult patients with moderate to severe rheumatoid arthritis (RA), who had an inadequate response or intolerance to a single TNF inhibitor other than Humira. In the study, Rinvoq demonstrated superiority versus Humira in the primary endpoint of achieving low disease activity and demonstrated superiority for additional ranked secondary endpoints at week 12. Rinvoq’s safety profile was consistent with previously reported studies, with no new safety risks identified.

•AbbVie announced that it completed its acquisition of Capstan Therapeutics. The acquisition adds a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate for B cell-mediated autoimmune diseases as well as a proprietary tLNP platform designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for tavapadon, a novel selective dopamine D1/D5 receptor partial agonist for the treatment of Parkinson’s disease (PD). The submission is supported by data from the Phase 3 TEMPO program, which demonstrated symptomatic improvement across the PD spectrum. If approved, tavapadon will enhance AbbVie’s position in PD by providing patients with a once daily oral treatment option.

•AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and efficacy of Botox (onabotulinumtoxinA) for the treatment of upper limb essential tremor. Botox met the primary endpoint in the Phase 2 trial, demonstrating a statistically significant improvement from baseline in the Tremor Disability Scale-Revised (TREDS-R) total unilateral score compared to placebo. The trial also met all six secondary endpoints. Results from safety analyses were generally consistent with the well-established safety profile of Botox.

•AbbVie announced that it completed its acquisition of Gilgamesh Pharmaceuticals’ lead investigational candidate, bretisilocin. Bretisilocin is a novel, short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser psychedelic compound with best-in-class potential, which is currently in Phase 2 clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Positive topline results from a Phase 2a study of bretisilocin in MDD were previously announced, demonstrating a clinically impactful and statistically significant reduction in severity of depressive symptoms versus low dose active comparator, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

•AbbVie announced submission of a new Biologics License Application (BLA) to the FDA for approval of pivekimab sunirine (PVEK), an investigational antibody-drug conjugate (ADC), for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer with significant need for innovative treatment options for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory (R/R) disease.

•At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, AbbVie presented new data from its ADC portfolio in patients with difficult-to-treat tumor types. Highlights included three oral presentations for Temab-A (telisotuzumab adizutecan) as a monotherapy or in combination across advanced, solid tumors, as well as new analysis of ABBV-706 for the treatment of R/R small cell lung cancer (SCLC).

•At the Society of Hematologic Oncology (SOHO) Annual Meeting, AbbVie announced updated results from the Phase 2 EPCORE NHL-6 trial evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of Epkinly (epcoritamab) monotherapy in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL.

•AbbVie announced plans to launch Elahere (mirvetuximab soravtansine-gynx) in the U.K. at a list price equal to the U.S., reflecting the advanced innovation and value of the treatment for adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the U.S.

•Allergan Aesthetics announced several marketing initiatives, which include a new national, multichannel, campaign highlighting Botox Cosmetic’s (onabotulinumtoxinA) market leadership, legacy and real-world patient experiences; the launch of a consumer education campaign that is aimed at providing clear, factual information about hyaluronic acid (HA) injectable fillers and the natural-looking results they can achieve; and the launch of SkinVive by Juvederm into 35 new markets.

•AbbVie announced it broke ground on a $195 million state-of-the-art active pharmaceutical ingredient (API) facility that will manufacture immunology, oncology and neuroscience medicines. This North Chicago, Ill. facility is expected to be fully operational and serving patients by 2027. The company also announced the start of construction on a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester, Mass., which will increase biologics manufacturing for immunology and oncology medicines. These projects are part of AbbVie’s previously announced commitment to invest more than $10 billion of capital in the U.S. to broadly support innovation and expand critical manufacturing capabilities and capacity.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $10.38 – $10.58 to $10.61 – $10.65, which includes an unfavorable impact of $2.05 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2025, as both cannot be reliably forecasted.

Company Declares Dividend Increase of 5.5 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.64 per share to $1.73 per share beginning with the dividend payable on February 17, 2026 to shareholders of record as of January 16, 2026. This reflects an increase of approximately 5.5 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the company’s inception in 2013, AbbVie has increased its quarterly dividend by more than 330 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

(Press release, AbbVie, OCT 31, 2025, View Source [SID1234659204])