Fruquintinib

CytomX's CX-2051 Shows Promising 28% Response Rate in Advanced Colorectal Cancer Phase 1 Trial

11 days ago

• CytomX's EpCAM-targeting antibody-drug conjugate CX-2051 demonstrated a 28% confirmed response rate in late-line colorectal cancer patients, significantly outperforming current standard therapies with single-digit response rates. • The novel PROBODY® masking technology appears to successfully target EpCAM, a previously "undruggable" tumor antigen, with manageable safety profile and no dose-limiting toxicities observed in the Phase 1 study. • Median progression-free survival reached 5.8 months with 43% response rate at the highest dose level (10 mg/kg), supporting plans to advance to Phase 2 trials in first half of 2026.

SUNLIGHT Trial Highlights Importance of Sequential Therapies in Refractory Colorectal Cancer

a month ago

• The SUNLIGHT trial demonstrated significant survival benefits when adding bevacizumab to trifluridine/tipiracil in refractory metastatic colorectal cancer, showing a 39% improvement in overall survival. • Despite having three FDA-approved regimens for refractory colorectal cancer (trifluridine/tipiracil plus bevacizumab, fruquintinib, and regorafenib), many patients don't receive all available treatment options. • Dr. John Marshall of Georgetown Lombardi Comprehensive Cancer Center emphasizes the need for personalized sequencing strategies and warns against non-medical factors influencing treatment decisions.

Fruquintinib-Sintilimab Combination Meets Primary Endpoint in Phase II/III RCC Trial

2 months ago

• The FRUSICA-2 Phase II/III study evaluating fruquintinib plus sintilimab as second-line treatment for advanced renal cell carcinoma has met its primary endpoint of progression-free survival. • The combination therapy demonstrated improvements in secondary endpoints including objective response rate and duration of response, offering new hope for patients who have progressed on previous therapies. • HUTCHMED and Innovent Biologics plan to submit detailed findings to regulatory authorities and progress toward NDA filings in the coming months.

Scotland Approves New Cancer Treatments for Prostate and Liver Cancers

2 months ago

• The Scottish Medicines Consortium (SMC) has approved talazoparib (Talzenna) in combination with enzalutamide for treating adults with prostate cancer, offering a targeted oral therapy option. • Cabozantinib (Cabozantinib Ipsen) has been accepted for treating adults with hepatocellular carcinoma (HCC) who have received previous treatment, expanding options for liver cancer patients. • The SMC rejected two other medications: ripretinib (Qinlock) for gastrointestinal stromal tumors and spesolimab (Spevigo) for generalised pustular psoriasis, citing cost-effectiveness and evidence uncertainties.

NICE Rejects Takeda's Fruzaqla for Advanced Colorectal Cancer Due to Cost Concerns

3 months ago

• NICE has issued draft guidance rejecting Takeda's Fruzaqla (fruquintinib) for advanced colorectal cancer treatment on the NHS, citing insufficient cost-effectiveness despite proven survival benefits. • The oral VEGF receptor inhibitor, licensed from Hutchmed for $400 million, demonstrated a 33% reduction in death risk compared to placebo in late-stage trials FRESCO and FRESCO-2. • Takeda expresses commitment to working with NICE and NHS England to address uncertainties, while the Scottish Medicines Consortium decision is expected in Q2 2025.

Fruquintinib Plus Trifluridine/Tipiracil Shows Promise in Pretreated Metastatic Colorectal Cancer

4 months ago

• A phase 2 trial combining fruquintinib and trifluridine/tipiracil demonstrated clinical activity in heavily pretreated metastatic colorectal cancer (mCRC) patients. • The combination therapy achieved a median progression-free survival (PFS) of 6.33 months and a median overall survival (OS) of 18.4 months. • The safety profile of the combination was acceptable, with treatment-related adverse events primarily being hematologic in nature. • These findings suggest that fruquintinib plus trifluridine/tipiracil could be a potential alternative treatment option for mCRC patients who have progressed on prior therapies.

Health Canada Approves Fruquintinib (Fruzaqla) for Metastatic Colorectal Cancer

4 months ago

• Health Canada has approved fruquintinib (Fruzaqla) for adults with metastatic colorectal cancer (mCRC) who have been previously treated with standard therapies. • The approval was based on data from the FRESCO-2 and FRESCO phase 3 trials, which demonstrated improved overall survival compared to placebo. • Fruquintinib is an oral inhibitor of VEGF receptors 1, 2, and 3, working by blocking the formation of new blood vessels in tumors. • This approval provides a new treatment option for Canadian mCRC patients who have limited alternatives, offering hope for slowing disease progression.

Fruquintinib Plus Sintilimab Shows Promise in Advanced Renal Cell Carcinoma

4 months ago

• A Phase Ib/II trial of fruquintinib plus sintilimab demonstrates promising efficacy in both treatment-naive and previously treated advanced clear cell renal cell carcinoma (ccRCC) patients. • In treatment-naive patients, the combination therapy achieved a confirmed objective response rate (ORR) of 68.2% with an 18-month progression-free survival rate of 59.4%. • Previously treated patients experienced a 60.0% confirmed ORR and a median progression-free survival of 15.9 months with the fruquintinib and sintilimab regimen. • The combination was generally well-tolerated, with manageable adverse events, supporting further investigation in the ongoing Phase III FRUSICA-02 study.

Cytokinetics and Pyxis Oncology Announce Key Milestones for 2025; CytomX Prioritizes Pipeline

5 months ago

• Cytokinetics anticipates a pivotal year in 2025, focusing on the potential FDA approval and commercial launch of aficamten for obstructive hypertrophic cardiomyopathy (HCM) in the U.S. • Pyxis Oncology is prioritizing the advancement of PYX-201, a novel antibody-drug conjugate (ADC), with data readouts expected in the second half of 2025 and the first half of 2026. • CytomX Therapeutics is focusing on its lead program, CX-2051, an EpCAM-targeting PROBODY ADC for advanced metastatic colorectal cancer, with initial Phase 1a data expected in 1H 2025.

Biomarker-Guided Therapies Transform Treatment Landscape Across Multiple Cancers

5 months ago

• Recent advances in targeted therapies including KRAS, BRAF, and CLDN18.2 inhibitors are revolutionizing treatment approaches for pancreatic, colorectal, lung and gastric cancers through molecular profiling-guided precision medicine. • Zolbetuximab plus chemotherapy demonstrated significant survival benefits in CLDN18.2-positive gastric cancer, while KRAS inhibitors showed promising response rates of 20-45% in pancreatic cancer patients with specific mutations. • Multiple biomarker-targeted approaches including HER2, PD-L1, and FGFR2 are expanding treatment options across gastrointestinal cancers, though optimal sequencing strategies are still being determined.

Fruzaqla (Fruquintinib) Launched in Japan by Takeda for Metastatic Colorectal Cancer

6 months ago

• Takeda has launched Fruzaqla (fruquintinib) in Japan following approval by the Japanese Ministry of Health, Labour and Welfare for previously treated metastatic colorectal cancer. • Fruzaqla is the first novel oral targeted therapy approved in Japan for metastatic CRC in over a decade, regardless of biomarker status, offering a new treatment option for patients. • The approval was based on the Phase III FRESCO-2 trial, which demonstrated consistent benefits in patients treated with fruquintinib, and Takeda holds the exclusive worldwide license outside mainland China. • HUTCHMED will receive a milestone payment from Takeda, marking continued progress in their global partnership to provide a differentiated treatment for metastatic CRC patients.

Fruzaqla (Fruquintinib) Gains Momentum in Europe and Japan for Metastatic Colorectal Cancer Treatment

6 months ago

• HUTCHMED will receive a $10 million milestone payment from Takeda after Fruzaqla (fruquintinib) secured its first national reimbursement in Europe, specifically in Spain, for treating metastatic colorectal cancer (CRC). • Takeda launched Fruzaqla in Japan following its approval in September 2024, marking the first novel oral targeted therapy for metastatic CRC approved in Japan in over a decade, regardless of biomarker status. • Fruquintinib, a selective oral inhibitor of VEGF receptors, has now been approved in multiple regions including the United States, Europe, Japan, and China, offering a new treatment option for patients with previously treated metastatic CRC.

Takeda's Growth & Launch Portfolio Drives H1 2024 Revenue Increase; Full-Year Guidance Revised

7 months ago

• Takeda reported a 5% revenue increase in H1 2024, driven by an 18.7% growth in its Growth & Launch product portfolio, offsetting declines in VYVANSE sales. • The company raised its full-year guidance due to strong H1 performance and updated foreign exchange assumptions, while core operating profit margin reached 30.2%. • Takeda is actively investing in late-stage pipeline programs, including Phase 3 trials for TAK-861 (narcolepsy) and mezagitamab (IgA nephropathy). • Despite robust performance, Takeda anticipates challenges in H2 due to accelerated generic erosion of VYVANSE and increased R&D spending.

Takeda's Growth Products Drive Strong First Half, Phase 3 Trial of TAK-861 Initiated

7 months ago

• Takeda reports a 13.4% revenue increase in the first half of FY2024, driven by Growth & Launch Products, including ENTYVIO, and geographical expansion with ADZYNMA and FRUZAQLA. • The company has initiated a Phase 3 trial for TAK-861 in narcolepsy type 1, showcasing advancements in its late-stage pipeline and commitment to developing life-transforming treatments. • Takeda upgrades its full-year forecasts, reflecting stronger-than-anticipated performance and revised foreign exchange assumptions, while planning to increase R&D investment in the second half. • Management Guidance for FY2024 has been upgraded, with Core Revenue expected to be flat to slightly increasing and Core Operating Profit decline in the mid-single-digit percentages.

FDA Approves New Cancer Treatments Amidst Rising Global Cancer Rates

8 months ago

• The FDA issued 16 oncology approvals between July and September 2024, addressing the global surge in cancer cases, particularly among individuals under 50. • Oncolytics Biotech is advancing pelareorep, with plans to submit a clinical trial for HR+/HER2- breast cancer to the FDA in early 2025, following positive BRACELET-1 trial results. • AbbVie has submitted a BLA for telisotuzumab vedotin for previously treated non-small cell lung cancer (NSCLC) with c-Met protein overexpression. • HUTCHMED's partner, Takeda, received approval in Japan for FRUZAQLA (fruquintinib) for previously treated metastatic colorectal cancer (CRC).

Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease

8 months ago

• Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment. • The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients. • Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden. • Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.

Fruquintinib Approved in Japan for Previously Treated Metastatic Colorectal Cancer

8 months ago

• Takeda's Fruzaqla (fruquintinib) has been approved in Japan for advanced or recurrent colorectal cancer (CRC) after chemotherapy. • The approval is based on the Phase III FRESCO-2 trial, which demonstrated statistically significant improvements in overall and progression-free survival. • Fruquintinib is the first novel targeted therapy approved in Japan for metastatic CRC, regardless of biomarker status, in over a decade. • This approval expands the global availability of fruquintinib, offering a new treatment option for patients with limited alternatives.

Cyramza Plus Lonsurf Fails to Improve Overall Survival in Metastatic Colorectal Cancer

8 months ago

• The phase 3 IKF-AIO-RAMTAS trial showed that adding Cyramza to Lonsurf did not significantly improve overall survival in heavily pretreated metastatic colorectal cancer patients. • Subgroup analysis revealed potential benefits in female patients and those with left-sided tumors, who experienced improved survival outcomes with the Cyramza/Lonsurf combination. • While overall survival was not significantly extended, the combination of Cyramza and Lonsurf did demonstrate a significant improvement in progression-free survival. • The combination therapy showed a manageable safety profile, though with a higher incidence of treatment-related side effects, particularly those associated with Cyramza.

Novel Drug Development Advances in Metastatic Colorectal Cancer: Focus on KRAS Targeting and Immunotherapy

9 months ago

• Recent therapeutic advances including trifluridine/tipiracil plus bevacizumab and fruquintinib have expanded treatment options for refractory metastatic colorectal cancer patients. • Significant progress is being made in targeting previously "undruggable" mutations, with promising developments in KRAS G12C inhibition and emerging pan-KRAS inhibitors. • While immunotherapy use remains limited to microsatellite instability-high patients, new approaches combining checkpoint inhibitors with VEGF TKIs show potential for broader application.

Drug Development Updates