On February 17, 2025 Rznomics reported on the 14th that its anticancer drug, RZ-001, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Hepatocellular Carcinoma (HCC) (Press release, Rznomics, FEB 17, 2025, View Source [SID1234650319]).

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This marks the second Fast Track Designation for RZ-001, following its designation in November 2023 for Glioblastoma (GBM), a hard-to-treat brain cancer.

The Fast Track program, established by the FDA, supports the development of drugs for serious or life-threatening diseases by expediting the approval process. Once a drug is designated and if relevant criteria are met, it benefits from accelerated review and approval, as well as more frequent and flexible communication with the FDA. Additionally, during the Biologics License Application review, a rolling review can be conducted for each data section, providing an advantage in the evaluation process.

RZ-001 is an anticancer drug developed using Trans-splicing Ribozyme, Rznomics’ proprietary RNA editing platform technology. It has received Investigational New Drug (IND) approval from both South Korea’s Ministry of Food and Drug Safety (MFDS) and the U.S. FDA. Currently, it is in Phase 1b/2a clinical trials for Hepatocellular Carcinoma (HCC) and Phase 1/2a trials for Glioblastoma (GBM).

Furthermore, for Glioblastoma (GBM), RZ-001 has been approved under the FDA’s Expanded Access Program (EAP), which allows compassionate use of investigational treatments outside clinical trials. The program is currently being conducted at Harvard University Hospital.

Dr. Seong-Wook Lee, CEO of Rznomics, stated, "We believe this designation recognizes the potential of RZ-001 as an innovative cancer therapy. We are committed to expediting its clinical development to provide effective treatment options for patients suffering from hard-to-treat cancers."

On February 17, 2025 Crown Bioscience, a global contract research organization (CRO) headquartered in the United States and a part of JSR Life Sciences and Japan-based JSR Corporation, reported the complete integration of Indivumed Services (Press release, Crown Bioscience, FEB 17, 2025, View Source [SID1234650318]). This strategic move, following the acquisition in 2023, solidifies Crown Bioscience’s standing in oncology drug research and development. As a result of this merger, the Indivumed Services brand will be fully retired in February 2025.

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The merger unifies the strengths of both entities, offering pharmaceutical and biopharmaceutical partners a powerful toolkit of integrated platforms and services, including biospecimen solutions, to enhance the oncology drug development process from discovery through to clinical stages. Crown Bioscience will maintain operations across 11 locations in the United States, Europe, and the Asia-Pacific region and will continue to be dedicated to consistently delivering expanded services and leading research platforms on a global scale.

On February 16, 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, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, reported that its first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363, has received its second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) (Press release, Innovent Biologics, FEB 16, 2025, View Source [SID1234650312]). This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy. IBI363 has demonstrated encouraging efficacy and safety across multiple solid tumor types. Currently, Innovent is conducting Phase 1/2 clinical trials of IBI363 mainly in China and the U.S.

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At the World Conference on Lung Cancer (WCLC) in September 2024, IBI363 presented promising efficacy signals in patients with sqNSCLC who had previously received immunotherapy:

In the 3 mg/kg dose group, among patients with at least 12 weeks of follow-up or study completion (n=18), the objective response rate (ORR) was 50.0%, and the disease control rate (DCR) was 88.9%. The median progression-free survival (PFS) has not yet been reached and remains under follow-up.
In the 1/1.5 mg/kg dose group, the median PFS was 5.5 months (95% CI: 1.5, 8.3), with a 12-month PFS rate of 30.7%, highlighting the potential long-term benefits of immunotherapy.
Across the 1/1.5/3 mg/kg dose groups, patients with PD-L1 TPS<1% (n=22) and those with PD-L1 TPS≥1% (n=22) achieved encouraging ORRs of 36.4% and 31.8%, respectively, suggesting IBI363’s potential advantage in PD-L1 low-expression populations.
Dr. Hui Zhou, Senior Vice President of Innovent, stated, "We are pleased that IBI363 has been granted Fast Track Designation by the FDA for sqNSCLC, following its previous designation for melanoma. Earlier, we reported that in an expanded cohort of sqNSCLC patients, IBI363 showed a trend toward improved ORR and DCR at higher doses, along with a manageable safety profile. The latest PFS data from the 3 mg/kg dose group after longer follow-up further strengthens our confidence in IBI363’s potential as an immunotherapy offering long-term benefits to patients. We will present the relevant data at upcoming academic conferences this year. More encouragingly, IBI363 has demonstrated potent anti-tumor activity regardless of PD-L1 expression levels. This suggests that IBI363 may not only advance treatment for immunotherapy-resistant populations but also for cold tumors with low or no PD-L1 expression. In addition to lung cancer, we have observed encouraging efficacy signals in cold tumors, including colorectal cancer and mucosal melanoma, with melanoma already advancing to pivotal clinical stages. Moving forward, we will continue to explore IBI363 in early-line treatment and in combination therapies."

Fast Track Designation (FTD) is a regulatory process designed to expedite the clinical development and review of drugs intended to treat serious conditions and address unmet medical needs. Drug candidates granted FTD benefit from increased communication with the FDA throughout subsequent drug development, potentially accelerating their clinical development and approval process.

About IBI363 (First-in-class PD-1/IL-2α-bias bispecific antibody fusion protein))

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. It is a PD-1/IL-2 bispecific antibody fusion protein designed to enhance efficiency while minimizing toxicity. The IL-2 arm of IBI363 has been engineered to optimize therapeutic effects with reduced side effects, while the PD-1 binding arm enables PD-1 blockade and selective IL-2 delivery. By simultaneously inhibiting the PD-1/PD-L1 pathway and activating the IL-2 pathway, IBI363 facilitates more precise and efficient targeting and activation of tumor specific T cells. Preclinical studies have shown that IBI363 exhibits strong anti-tumor activity across multiple tumor-bearing pharmacological models, including those resistant to PD-1 inhibitors and metastatic models. Additionally, it has demonstrated a favorable safety profile in preclinical models. Clinical trials are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies.

About Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Lung cancer is the most common and deadliest malignancy worldwide, including in China[1], posing a significant public health challenge. Non-small cell lung cancer (NSCLC) accounts for more than 80% of all lung cancer cases[2], with squamous cell carcinoma being one of its two major subtypes[2]. In recent years, immune checkpoint inhibitors have transformed the treatment landscape for NSCLC. However, for patients with NSCLC who have failed immunotherapy and lack driver gene mutations, there remains a significant and urgent unmet need for effective treatment options. The standard second- or third-line treatment, docetaxel, offers limited efficacy, with a median progression-free survival (PFS) of less than four months[3],[4]. While antibody-drug conjugates (ADCs) have shown promise, two large Phase 3 studies in squamous NSCLC have yet to demonstrate satisfactory efficacy.

On February 15, 2025 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; SB16; 120 mg vial), biosimilars referencing Prolia and Xgeva respectively (Press release, Samsung BioLogics, FEB 15, 2025, View Source [SID1234650314]). In addition, the FDA granted a provisional determination for both Ospomyv and Xbryk’s interchangeability designation.

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OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at high risk for fracture, treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer and for the treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

XBRYK, referencing Xgeva, has been approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

"The FDA approval of OSPOMYV and XBRYK marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US. By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life," said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. "This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas."

The FDA approval was based on totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were met, in terms of area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration.1 In addition, a randomized, double-blind, multi-center Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, PK, and pharmacodynamics (PD) profiles between SB16 and reference denosumab (DEN) in postmenopausal osteoporosis (PMO) patients. The primary endpoint was met in terms of percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12, and a follow-up up to Month 18 demonstrated switching to SB16 from DEN were comparable up to Month 18 in terms of efficacy, PK, PD, safety and immunogenicity.2,3

OSPOMYV and XBRYK, marks Samsung Bioepis’ 9th and 10th FDA approved medicines as well as the company’s first FDA approval for an endocrinology biosimilar, setting another milestone for the company to broaden its biosimilar portfolio that cover a spectrum of therapeutic areas including immunology, oncology, ophthalmology, hematology and endocrinology.

OSPOMYV (denosumab-dssb) injection, for subcutaneous use

Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment:

of postmenopausal women with osteoporosis at high risk for fracture
to increase bone mass in men with osteoporosis at high risk for fracture
of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
SELECTED SAFETY INFORMATION

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE

See full prescribing information for complete boxed warning.

Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported.
The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia.
Prior to initiating Ospomyv in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Ospomyv in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.

CONTRAINDICATIONS

Hypocalcemia
Pregnancy
Known hypersensitivity to denosumab products
WARNINGS AND PRECAUTIONS

Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Ospomyv. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium.
Same Active Ingredient: Patients receiving Ospomyv should not receive other denosumab products concomitantly.
Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms.
Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Ospomyv is discontinued.
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Ospomyv if severe symptoms develop.
Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

XBRYK (denosumab-dssb) injection, for subcutaneous use

Xbryk is a RANK ligand (RANKL) inhibitor indicated for:

Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
SELECTED SAFETY INFORMATION

CONTRAINDICATIONS

Hypocalcemia
Known clinically significant hypersensitivity to denosumab products
WARNINGS AND PRECAUTIONS

Same Active Ingredient: Patients receiving Xbryk should not receive other denosumab products concomitantly.
Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs.
Hypocalcemia: Denosumab products can cause severe symptomatic hypocalcemia. Fatal cases have been reported with denosumab products use. Correct hypocalcemia prior to initiating Xbryk. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting Xbryk. Monitor for symptoms. Avoid invasive dental procedures during treatment with Xbryk.
Atypical femoral fracture: Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: When Xbryk treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.
These highlights do not include all the information needed to use XBRYK safely and effectively. See full prescribing information for XBRYK HERE, which includes the Boxed Warning, Medication Guide and Instructions for Use.

On February 15, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in an oral plenary session by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (Press release, Arcus Biosciences, FEB 15, 2025, View Source [SID1234650313]).

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"The newest data are from the 100mg cohort using the tablet formulation and the expected go-forward dose for pivotal studies, which showed a 33% confirmed response rate despite the relatively short follow-up," said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. "Casdatifan continues to be well tolerated, with a very low discontinuation rate, supporting its strong potential in combination therapy. We look forward to sharing initial results for the casdatifan plus cabozantinib cohort later this year."

ARC-20 is a Phase 1/1b dose-escalation and expansion study. New data include mPFS and ORR for the 50mg BID cohort, and ORR for the 50mg once-daily (QD) and 100mg QD (tablet) cohorts, all of which evaluated casdatifan in patients with metastatic clear cell renal cell carcinoma (ccRCC), most of whom had progressed on at least two prior lines of therapy, including both an anti-PD-1 and a VEGFR tyrosine kinase inhibitor (TKI) therapy. The patient population was heavily pretreated; more than half (52-59%) of subjects received at least three prior lines of therapy and approximately one quarter (24-29%) had received at least four prior lines of therapy. Most patients (70-76%) had an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk factor of intermediate or poor.

Casdatifan showed improvement in primary progressive disease rate (progressed at or before their first disease assessment), ORR and mPFS relative to published data from studies with HIF-2a inhibitors to date. At the time of data cut off (DCO, January 3, 2025), most patients (81-87%) experienced disease control with either a partial response or stable disease, and most were still on treatment. The median duration of response had not been reached, with all but two of the 26 responders across all three cohorts still on treatment.

No unexpected safety signals were observed at the time of DCO, and casdatifan had an acceptable and manageable safety profile across all doses. Across all three cohorts, only one patient discontinued treatment as a result of anemia and only two due to hypoxia. A summary of the efficacy and safety results is below.

50mg BID

(n=32)

50mg QD

(n=28)

100mg QD Tablet

(Go-forward dose)

(n=27)

Efficacya

Median Follow-Up

15 months

12 months

5 monthsb

Median Progression-Free Survival (95% CI)

9.7 months

(5.5, NE)

NE

(6.8, NE)

NE

Confirmed ORR (cORR) per RECIST v1.1 [95% CI]

25% (8)c

[11.5-43.4]

32% (9)c

[15.9-52.4]

33% (9)

[16.5-54.0]

Best Overall Responsed:

31% (10)

32% (9)

33% (9)

Complete Response

0

4% (1)

0

Partial Response

31% (10)

29% (8)

33% (9)

Stable Disease

50% (16)

54% (15)

52% (14)

Progressive Disease

19% (6)

14% (4)

15% (4)e

Median Time to Response

2.8 months

4.1 months

1.6 months

Disease Control Rate

[95% CI]

81%

[63.6-92.8]

86%

[67.3-96.0]

85%

[66.3-95.8]

CI: confidence interval; NE: not estimable

a Efficacy-evaluable population for this expansion cohort is defined as all eligible participants who received any study treatment and have at least one post-baseline efficacy assessment, or who discontinued study treatment due to progressive disease or death.
b Majority of patients (n=21) were still on treatment at time of DCO.
c In the 50mg BID cohort, one unconfirmed responder remains on treatment. In the 50mg QD cohort, one unconfirmed responder became a confirmed responder after the DCO, increasing the cORR to 32%.
d Unconfirmed best overall response.
e Includes two patients with radiological progressive disease and two patients who had clinical progression before the first scan.

50mg BID

(n=33)

50mg QD

(n=31)

100mg QD Tablet

(Go-forward dose)

(n=29)

Safetya

Any Serious Treatment-Emergent Adverse Events (TEAEs) related to casdatifan

3% (1)

10% (3)

7% (2)

Grade ≥3 TEAEs related to casdatifan

Anemia

42% (14)

32% (10)

17% (5)

Hypoxia

9% (3)

7% (2)

10% (3)

a The safety-evaluable population included all dose expansion enrolled patients who received any amount of any study treatment.

Arcus is pursuing a broad development program in both the immuno-oncology (IO)-naive and post-IO settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. These studies include:

Arcus’s planned Phase 3 study, PEAK-1, which will evaluate casdatifan in combination with cabozantinib versus cabozantinib monotherapy as a first- or second-line treatment in patients with metastatic ccRCC who have previously received anti-PD-1 therapy. The primary endpoint will be PFS with a key secondary endpoint of overall survival.
A planned Phase 1b study operationalized by AstraZeneca (part of the eVOLVE portfolio) to evaluate casdatifan in combination with volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody.
Initiation of two additional cohorts in ARC-20 to evaluate casdatifan in first-line settings.
Investors may dial in to the conference call at +1 404 975 4839 (local) or +1 833 470 1428 (toll-free) using Conference ID: 331780 on Tuesday, February 18, 2025, at 5:00 AM PT / 8:00 AM ET. Participants may also register for the call online using the following link: View Source To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a transcription factor responsible for activating multiple tumor growth pathways in hypoxic and pseudo-hypoxic tumor environments. By selectively binding HIF-2a, casdatifan is designed to shut down hypoxic oncogenesis and key oncogenic pathways leading to cancer cell death. Clear cell RCC (ccRCC) is almost universally associated with HIF-2a dysregulation. Casdatifan is currently being evaluated in ARC-20, a Phase 1/1b study in renal cell carcinoma and other cancers.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.