On March 18, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13), reported that the FRUSICA-2 Phase 2/3 clinical trial evaluating sintilimab in combination with fruquintinib as second-line treatment for locally advanced or metastatic renal cell carcinoma (RCC) in China has met its primary endpoint of progression free survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) (Press release, Innovent Biologics, MAR 18, 2025, View Source [SID1234651242]).

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The combination of sintilimab and fruquintinib received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the FRUSICA-1 study (NCT03903705).

The FRUSICA-2 study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC (NCT05522231). In addition to the primary endpoint PFS, the combination also demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR). Full results will be submitted for presentation at an upcoming scientific conference.

Prof Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study, said: "The rapid advancements in targeted therapies, immunotherapies, and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Targeted therapy remains an indispensable and crucial component in systemic treatment of advanced RCC in China. Optimizing the selection of targeted therapy, either as monotherapy or in combination with immunotherapy, for individual patients is a key focus of clinical interest. The results from the FRUSICA 2 study underscore the potential of the sintilimab and fruquintinib combination to address the pressing medical needs of patients with this challenging disease."

Prof Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study, said: "The positive results from this Phase 3 study of the sintilimab and fruquintinib combination represent a significant advancement in the treatment of advanced renal cell carcinoma. We are optimistic about the clinical implications of the findings as we strive to provide more effective treatment options for patients who may not have had adequate responses to previous therapies."

Dr Hui Zhou, Senior Vice President of Innovent, stated: "We are encouraged by the positive results in the FRUSICA-2 clinical trial. These outcomes not only underscore the great potential of the combination therapy of sintilimab and fruquintinib but also bring new hope to previously treated patients with advanced renal cell carcinoma. We look forward to working closely with HUTCHMED to jointly advance the registrational communication of this innovative combo therapy and make it available to patients as soon as possible."

Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED, stated: "The encouraging results from our study provide clear evidence for the combination of fruquintinib and sintilimab as a viable new treatment option for advanced renal cell carcinoma patients who have progressed on previous therapy. This not only reaffirms our commitment to advancing cancer therapies but also represents an important step forward in addressing unmet medical needs within this patient population. I extend my heartfelt gratitude to the patients and investigators who participated in this research; their contributions have been vital to our success. We look forward to sharing detailed findings with regulatory authorities and progressing toward NDA filings in the coming months."

About Kidney Cancer and RCC

It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[i] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[ii] Approximately 90% of kidney tumors are RCC.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.[iii]

In China, sintilimab has been approved and included in the updated NRDL for seven indications. The updated NRDL reimbursement scope for TYVYT (sintilimab injection) includes:

For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Furthermore, sintilimab’s eighth indication, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, was conditional approved by the NMPA in December 2024. And the NDA for sintilimab in combination with ipilimumab as neoadjuvant treatment for resectable MSI-H/dMMR colon cancer is under the NMPA review and has been granted Priority Review designation.

In addition, three clinical studies of sintilimab have met their primary endpoints:

Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
Phase 3 study of sintilimab monotherapy as second-line treatment for squamous non-small cell lung cancer with disease progression following platinum-based chemotherapy;
Phase 2/3 study of sintilimab in combination with fruquintinib versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC.
About Fruquintinib

Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor (VEGF) receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy.[iv]

About Fruquintinib Approvals

Fruquintinib is co-developed and co-marketed in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib.

The combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) has conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA. Fruquintinib received approval for the treatment of previously treated metastatic colorectal cancer in the US in November 2023, in the EU in June 2024, in Switzerland and Argentina in August 2024, in Canada, Japan and the United Kingdom in September 2024, in Australia and Singapore in October 2024 and in Israel and the United Arab Emirates in December 2024. Regulatory applications are progressing in many other jurisdictions.

The global regulatory submissions are based on data from two large, randomized, controlled Phase III trials in colorectal cancer, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 metastatic colorectal cancer patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023,[v] while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA.[vi]

The safety and efficacy of fruquintinib for the following investigational uses have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated:

About Fruquintinib for Second-line Treatment of RCC

The U.S. Food and Drug Administration (FDA) has approved five immune-oncology combination therapies for the first-line treatment of advanced RCC. However, only one immune-oncology combination therapy has been approved in China for advanced RCC patients classified as having intermediate or poor risk by the International mRCC Database Consortium (IMDC). Single-agent targeted therapy continues to be one of the primary choices for first-line treatment of advanced RCC in China. Notably, advanced RCC patients who have experienced failure with single-agent targeted therapy previously still indicate an unmet medical need.

Results from a proof-of-concept Phase Ib/II study of fruquintinib plus sintilimab were published in Targeted Oncology in January 2025. The combination demonstrated promising efficacy and a tolerable safety profile in this setting. At the data cutoff of October 9, 2024, all 20 enrolled previously treated patients were evaluable for efficacy, with a median follow-up duration of 45.7 months. The confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9 months and median PFS was 15.9 months. Overall survival ("OS") was not reached, and the 36-month OS rate was 58.3%.

On March 18, 2025 Oncorena reported that the FDA has approved the Company’s IND application to initiate the Phase I/II study Oncorella-1: A Phase 1/2, open label, single arm study on safety, tolerability and anti-tumor efficacy of orellanine treatment in patients with metastatic clear-cell or papillary renal cell carcinoma (NCT05287945, ONC001-CL-001) (Press release, Oncorena, MAR 18, 2025, View Source [SID1234651241]).

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In the study Oncorella-1, up to 75 patients with severe metastatic renal cancer requiring dialysis will be enrolled. These patients have exhausted their treatment options and ONC175 represents a potentially new first-in-class treatment for patients with urgent unmet medical need.

The study is currently being conducted at Karolinska University Hospital in Stockholm, Sweden.

Börje Haraldsson, CEO & co-founder of Oncorena comments:

"This approval brings us closer to being able to evaluate the potential for this novel treatment in patients in desperate need for new and better options. We are excited to start the first US site, MD Andersson in Houston, Texas, where the study will be led by investigator Professor Nizar Tannir, a world-leading expert in renal cancer."

About ONC175

ONC175 is an investigational drug product under development that contains synthetically produced orellanine as active ingredient. Orellanine is highly specific to the kidney and induces irreversible renal failure. It is clinically well-known that orellanine does not affect organs other than the kidneys.

In pioneering preclinical studies ONC175 demonstrated a powerful and highly organ-specific mode of action capable of eradicating human metastatic renal cancer cells. The primary goal is to develop ONC175 as a potential curative treatment of metastatic renal cell carcinoma in patients with no remaining kidney function, i.e., patients on dialysis.

About kidney cancer

Approximately 400,000 patients are affected by kidney cancer globally according to the WHO. The disease can often be cured by surgery if detected early, but the prognosis is less favorable if there are metastases. Today, the disease is treated with various types of targeted and immuno-active drugs, that seldom are curative. There is therefore a great and urgent unmet medical need for new, effective and safe drugs.

On March 18, 2025 Medison Pharma , a global company focused on accelerating access to highly innovative therapies in international markets, and Immunocore Holdings plc (NASDAQ: IMCR), a commercial-stage biotechnology company pioneering the delivery of transformative immunomodulatory medicines to radically improve patient outcomes for cancer, infectious diseases and autoimmune diseases, reported that KIMMTRAK (tebentafuspe) has received approval for health registration by the National Health Surveillance Agency (ANVISA), under the regulatory approval pathway for rare diseases (Press release, Medison Pharma, MAR 18, 2025, View Source [SID1234651240]).

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Tebentafuspe is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mum). This is the first therapy approved by ANVISA for metastatic uveal melanoma in Brazil [1],[2] .
Uveal melanoma is a rare and aggressive eye cancer with limited treatment options available at an advanced stage. Once metastasized, it carries a poor prognosis, and survival rates have remained largely unchanged for decades [ 3] . Developed by Immunocore,
tebentafuspe is an innovative immune mobilization monoclonal T-cell receptor therapy against cancer (ImmTAC) [ 4] designed to engage the body’s immune system to specifically target and destroy uveal melanoma cells.
As part of their long-standing global partnership, Medison and Immunocore are collaborating to bring this therapy to Latin America and beyond the U.S., Japan and Western Europe. Brazil has become the first country in the region to obtain approval for the drug, which offers a new treatment option for patients living with this disease [ 5] .

Mark Moyer , Senior Vice President of Regulatory Sciences at Immunocore said: "Following the approval of the registration, HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in Brazil can now access tebentafuspe. With approvals in 39 countries, this underscores Immunocore’s firm commitment to providing our medicines to patients who can benefit from them around the world."

The approval of tebentafuspe in Brazil underscores Medison’s commitment to expanding access to innovative oncology treatments in Latin America. Victor Papamoniodis , Chief Commercial Officer of Medison Pharma, said: "We are proud of our global partnership with Immunocore that allows us to bring this treatment to Brazilian patients who have not had access to an approved therapy until now. Medison is dedicated to providing the most advanced therapies for rare and serious diseases to patients around the world."

Edson Paixão, General Manager of Medison Pharma in Brazil, Andean Region, Central America and the Caribbean , reinforced: "Medison remains committed to accelerating access to highly innovative therapies for Brazilian patients. The approval of tebentafuspe is an important milestone, and we are proud to make this therapy available to patients who can benefit from it."

About KIMMTRAK (tebentafuspe)

Solution for dilution for infusion with 100 micrograms/0.5 mL in a pack containing 1 vial of 0.5 mL.

INTRAVENOUS USE

ADULT USE

WARNING: Cytokine Release Syndrome (CRS), which can be serious or life-threatening, has occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours after the first three infusions and then as clinically indicated.

Indications: As monotherapy for the treatment of adult patients with unresectable or metastatic uveal melanoma positive for human leukocyte antigen (HLA) A*02:01.

Patients treated with KIMMTRAK must have an HLA-A*02:01 genotype determined by any validated HLA genotyping assay.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed.

Warnings and Precautions: Most patients experienced CRS following tebentafuspe infusions. The diagnosis of CRS was most frequently based on pyrexia followed by hypotension and infrequently on hypoxia. Other symptoms commonly observed with CRS included chills, nausea, vomiting, fatigue, and headache. In most cases, CRS began on the day of infusion, with a median time to resolution of 2 days. Pyrexia was observed in nearly all cases of CRS, and in these patients, an increase in body temperature typically occurred within the first 8 hours after tebentafuspe infusion. CRS rarely (1.2%) led to discontinuation of treatment. Patients should be monitored for signs and symptoms of CRS for at least 16 hours after the first three tebentafuspe infusions in a hospital setting with immediate access to resuscitation drugs and equipment to manage CRS. If CRS is observed, immediate supportive care, including antipyretics, intravenous fluids, tocilizumab, or corticosteroids, should be initiated to prevent worsening of the syndrome or potential fatality, and monitoring should continue until resolution. With subsequent doses, patients should be closely monitored after treatment for early identification of signs and symptoms of CRS. Patients with comorbidities, including cardiovascular disorders, may be at increased risk of sequelae associated with CRS. Tebentafuspe treatment has not been studied in patients with clinically significant cardiac disease. Depending on the persistence and severity of CRS, tebentafuspe treatment should be withheld or discontinued. Acute skin reactions with infusion have been reported, including rash, pruritus, erythema, and skin edema. Cardiac events, such as tachycardia and sinus arrhythmia, have been observed in patients on treatment. Cases of QT prolongation have been reported following treatment with tebentafuspe. An electrocardiogram (ECG) should be performed on all patients before and after treatment, during the first 3 weeks and thereafter as clinically indicated. This medicine may potentiate QT interval prolongation, which increases the risk of serious ventricular arrhythmias such as "torsades de pointes", which is potentially fatal (sudden death). This medicine may cause hepatotoxicity. Therefore, it requires careful use, under strict medical supervision and accompanied by periodic controls of liver function, at the physician’s discretion.

Pregnancy and lactation: Women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose of treatment. The drug is not recommended during pregnancy and in women of childbearing potential who are not using contraception. Pregnancy in women of childbearing potential should be ascertained before starting treatment. There is insufficient information on the excretion of tebentafuspe/metabolites in human milk. A risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued during treatment with tebentafuspe.

Drug, food and alcohol interactions: No formal interaction studies have been performed with tebentafuspe. Initiation of tebentafuspe therapy causes a transient release of cytokines that may suppress CYP450 enzymes . The highest risk of drug-drug interactions occurs within the first 24 hours of the first three doses of tebentafuspe in patients who are receiving concomitant CYP450 substrates , particularly those with a narrow therapeutic index. These patients should be monitored for toxicity (e.g., warfarin) or drug concentrations (e.g., cyclosporine). The dose of concomitant medications should be adjusted as necessary.

Dosage: Hospitalization is recommended for at least the first three infusions. The recommended dose is 20 micrograms on Day 1, 30 micrograms on Day 8, 68 micrograms on Day 15, and 68 micrograms once weekly thereafter. Treatment should continue as long as the patient derives clinical benefit and in the absence of unacceptable toxicities. To minimize the risk of hypotension associated with CRS, intravenous fluids should be administered prior to initiating the infusion, based on clinical assessment and the patient’s volume status. Tebentafuspe should be withheld or discontinued to manage adverse reactions. The recommended infusion period is 15 to 20 minutes.

Adverse reactions and laboratory test abnormalities: The most common adverse reactions in patients treated with tebentafusp were CRS (88%), rash (85%), pyrexia (79%), pruritus (72%), fatigue (66%), nausea (56%), chills (55%), abdominal pain (49%), edema (49%), hypo/hyperpigmentation (48%), hypotension (43%), dry skin (35%), headache (32%), and vomiting (34%). Adverse reactions led to permanent discontinuation in 4% of treated patients. The most common adverse reaction resulting in discontinuation of tebentafusp was CRS. Adverse reactions resulting in at least one dose interruption occurred in 26% of treated patients (weekly dosing) and resulted in a median of one missed dose. Adverse reactions requiring dose interruption in ≥2% of patients included fatigue (3%; Grade 1-3), pyrexia (2.7%; Grade 1-3), alanine aminotransferase increased (2.4%; Grade 1-4), aspartate aminotransferase increased (2.4%; Grade 1-3), abdominal pain (2.1%; Grade 1-3), and lipase increased (2.1%; Grade 1-3). Adverse reactions leading to dose modification in ≥1% of patients were CRS (1.9%; Grade 1-3) and hypotension (1.1%; Grade 2-4). Very common adverse reactions were: CRS, decreased appetite, hypomagnesemia, hyponatremia, hypocalcemia, hypokalemia, insomnia, headache, dizziness, paresthesia, tachycardia, hypotension, flushing, hypertension, cough, dyspnea, nausea, vomiting, diarrhea, abdominal pain, constipation, dyspepsia, rash, pruritus, dry skin, hypo/hyperpigmentation, erythema, arthralgia, back pain, myalgia, pain in extremity, pyrexia, fatigue, chills, edema, influenza-like illness, increased aspartate aminotransferase, increased alanine aminotransferase, increased serum bilirubin, increased lipase, anemia, decreased lymphocyte count, decreased serum phosphate, increased serum creatinine. See other adverse reactions in the full product leaflet.

Registration: 1.9132.0001/ Medison Pharma Brasil Produtos Farmacêuticos LTDA /CNPJ 48.682.588/0001-37/ Rua Nelson Pontes , 125 Bloco 5 e 6. Jardim Margarida. Vargem Grande Paulista/SP/Indústria Brasileira/ KIMMTRAK/SAC: 0800-633-4766. SALE UNDER PRESCRIPTION. USE RESTRICTED TO HEALTHCARE ESTABLISHMENTS. If symptoms persist, a physician should be consulted. Scientific documentation and additional information are available from Customer Service and the service department for prescribers and dispensers of medication. Product information approved by Anvisa is available at View Source

On March 18, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, reported breakthrough preclinical findings demonstrating the efficacy of HT-KIT, a novel targeted therapy for gastrointestinal stromal tumors (GIST) (Press release, Hoth Therapeutics, MAR 18, 2025, View Source [SID1234651239]). The results highlight HT-KIT’s ability to significantly reduce tumor burden in humanized mouse models, disrupt KIT signaling pathways, and induce tumor cell death.

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"These exciting findings mark a significant milestone in the development of HT-KIT as a potential new therapeutic for patients with GIST," said Robb Knie, CEO of Hoth Therapeutics.

"By targeting KIT mutations, which are a major driver of GIST progression, HT-KIT has shown remarkable efficacy in preclinical models, demonstrating its potential as a transformative treatment option for this difficult-to-treat cancer."

Key Findings from the Preclinical Study:

Significant Reduction in KIT Expression – HT-KIT effectively reduced KIT receptor expression within 24 hours, with effects sustained for 72 hours.
Induction of Tumor Cell Death – HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, while the lower dose led to delayed but substantial cell death at 72 hours.
Decreased Tumor Cell Proliferation – HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, as confirmed by cell count reductions and decreased fluorescence intensity in proliferation assays.
Marked Tumor Volume Reduction in GIST Mouse Models – In a humanized xenograft model, HT-KIT treatment led to a significant reduction in tumor growth, with differences becoming statistically significant by day 8 and increasing over time.
Consistent Tumor Size Reduction – Excised tumors from HT-KIT-treated mice were smaller and lighter than those in the control group, reinforcing tumor volume measurements.
HT-KIT: A Potential New Treatment for GIST

GIST is a rare but aggressive cancer often driven by activating mutations in the KIT receptor. Current treatment options, including tyrosine kinase inhibitors (TKIs), can face resistance over time, leading to disease progression. Hoth Therapeutics’ HT-KIT offers a novel approach by effectively reducing KIT receptor expression, disrupting tumor survival pathways, and inhibiting tumor growth in vivo.

"These results provide compelling preclinical proof-of-concept for HT-KIT in GIST treatment," said Robb Knie. "By directly targeting the underlying genetic drivers of GIST, HT-KIT has the potential to overcome limitations of existing therapies and provide a new therapeutic strategy for patients with KIT-driven malignancies."

Next Steps in Development

Hoth Therapeutics is committed to advancing HT-KIT toward clinical evaluation. The company is currently conducting additional preclinical studies to further validate HT-KIT’s efficacy and safety profile, with plans to initiate regulatory discussions for first-in-human trials.

On March 18, 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 alternative to surgical tumor removal, reported that it exhibited at the 19th Annual St. Gallen Breast Cancer Conference in Vienna, Austria from March 12 – 15, 2025 (Press release, IceCure Medical, MAR 18, 2025, View Source [SID1234651238]). Six studies of ProSense in breast cancer were accepted as peer-reviewed abstracts, presented as e-posters during the conference, and are being published in the scientific journal, The Breast after the conference.

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"ProSense received a high level of interest at this prestigious breast cancer conference in Europe where our cryoablation system is gaining increasing commercial traction driven by regulatory approval and a growing body of efficacy and safety data from third party studies," IceCure’s Chief Executive Officer, Eyal Shamir commented. "Among the benefits of these investigator-initiated studies is that each practitioner studies different patient populations in varied settings and circumstances, producing a breadth and depth of data that would simply not be available even in the largest of company-sponsored global studies. We are grateful to the investigators as we all aim toward the same goal of advancing women’s health through innovation and collaboration."

The following studies of ProSense were presented:

The Impact of Adjuvant Treatment After Cryoablation in Early-Stage, Low-Risk Breast Cancer: ICE3 Trial 5-Year Ipsilateral Breast Tumor Recurrence (IBTR)
Lead author Dr. Richard Fine, United States
Summary conclusion: The ICE3 trial suggests that cryoablation with ProSense, complemented by adjuvant therapy, is a viable alternative to surgical excision for selected patients with early-stage, low-risk breast cancer with recurrence rates comparable to those following lumpectomy. The addition of endocrine therapy alone yields similar results to de-escalation trials omitting radiation after surgery, such as CALGB 9343, PRIME II and LUMINA, without sacrificing survival. ICE3 enrolled patients aged ≥60 with unifocal, hormone receptor-positive, HER2-negative invasive ductal carcinomas measuring ≤1.5 cm. At 5 years, the overall IBTR rate was 3.61% (7 recurrences out of 194 patients). The 124 Patients who received only endocrine therapy with cryoablation had a 5-year IBTR rate of 3.22% (4 recurrences out of 124 patients).
Expanding the Use of Cryoablation on T1 Breast Cancers: An Initial Experience
Lead Author Dr. Ava Kwong, Hong Kong
Summary conclusion: This study evaluated expanding ICE3’s inclusion criteria to T1 breast cancer of all IHC subtypes (i.e. luminal, HER2-enriched and triple negative breast cancers). The study found that cryoablation with ProSense can completely ablate T1 breast cancer, including triple negative breast cancer, and younger age range. 35 patients were recruited with a median age of 64 and biopsy proven invasive or in-situ breast cancer of ≤2cm.
The Treatment of Breast Cancer with Percutaneous Thermal Ablation: Results of the THERMAC trial
Lead Author by Dr. Linda Risks, Netherlands
Summary conclusion: Percutaneous thermal ablation has the potential to replace surgical treatment and improve the health-related quality of life of patients with small breast cancers, without jeopardizing current treatment effectiveness or safety. 41 postmenopausal patients, with cT1N0 ER+/Her2- breast cancer, were treated. The study compared radiofrequency ablation ("RFA"), microwave ablation ("MWA") and cryoablation ("CA"). The RFA arm was prematurely terminated. Complete ablation was reached in 72% (95% CI, 49% to 88%) in the MWA arm and in 94% (95% CI, 74% to 0.99) in the cryoablation arm. Adverse events occurred in 44% (95% CI, 25% to 66%) of the patients in the MWA arm and 0% (95% CI, 0% to 18%) of in the cryoablation arm. Of the three thermal ablation methods evaluated, cryoablation with ProSense was the only thermal ablative technique that met the minimum requirements and will therefore be selected for a Phase III trial.
Percutaneous Ultrasound-Guided Cryoablation for the Treatment of Breast Cancer in Non-Surgical Patients
Lead Author Dr. Lucía Graña López, Spain
Summary conclusion: Breast cancer patients who chose not to have surgery or were considered inoperable were treated with ProSense cryoablation, which was found to be a safe and well-tolerated outpatient procedure. The study outcomes suggest that cryoablation is effective and could be an alternative to surgery for the management of luminal breast cancer up to 2.5 cm. 60 breast cancer tumors were treated (median size 21 mm, range 6-46 mm) in 54 patients, median age 87, with ProSense cryoablation. Complete tumoral necrosis was achieved in 49 tumors (81.7%). Axillary progression occurred in two cases of triple-negative breast cancer. Two patients experienced recurrence in different locations. Percutaneous cryoablation was successful in 100% of luminal cancers up to 2.5 cm. The procedure was well tolerated, with no major complications observed.
Cryoablation of Breast Cancer: The Challenge of an Innovative Non-Surgical Treatment for Selected Patients
Lead Author Dr. Francesca Magnoni, Italy
Summary conclusion: The European Institute of Oncology in Italy is evaluating ProSense cryoablation, with the prospective observational study "Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE)". The trial has just started and will enroll 233 patients over the age of 50 years with unifocal, small (≤1.5 cm), clinically node-negative, luminal A and B breast cancer. To date, 11 patients eligible for cryoablation have been enrolled. Cryoablation, performed on an outpatient basis under local anesthesia, completely replaces both breast and axillary surgery, in accordance with recent evidence.
Cryotherapy as a Surgical De-Escalation Strategy in Breast Cancer: A Comprehensive Review of Techniques, Complications, and Oncological Outcomes
Lead author Dr. Kai Lin Lee, Singapore
Summary conclusion: After a review of 276 papers, this study concluded that cryotherapy with systems including ProSense could potentially be a step forward in surgical de-escalation of breast cancer, particularly for elderly patients with early-stage breast cancer or those who are at high risk and might benefit from a less aggressive treatment strategy.

About ProSense
The ProSense Cryoablation System 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 breast, kidney, lung, and liver.

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 that door to fast and convenient office-based procedures for breast tumors.