Sorafenib

FDA Approves BMS's Opdivo/Yervoy Combination for First-Line Treatment of Advanced Liver Cancer

a month ago

• Bristol-Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) combination has received FDA approval for first-line treatment of unresectable or metastatic hepatocellular carcinoma, demonstrating a 21% reduced risk of death compared to standard therapies. • The CheckMate-9DW trial showed significant survival benefits with a median overall survival of 23.7 months for the immunotherapy combination versus 20.6 months for tyrosine kinase inhibitors, potentially establishing a new standard of care. • This approval marks a significant advancement for HCC patients, addressing an unmet need in a disease whose incidence has tripled over four decades, though treatment decisions may be influenced by the combination's known toxicity profile.

Nirogacestat Shows Deepening Long-Term Responses in Desmoid Tumor Patients

2 months ago

• Long-term treatment with nirogacestat (Ogsiveo) demonstrated improved objective response rates reaching 45.7% at 4 years compared to 34.3% at 1 year in patients with desmoid tumors, according to updated DeFi trial data. • Patients experienced significant quality-of-life benefits with nirogacestat, including rapid pain reduction within two weeks of treatment initiation, allowing many to discontinue opioid medications despite minimal initial changes in tumor imaging. • While 75% of female patients experienced reversible ovarian dysfunction with nirogacestat, the study confirmed that ovarian function returned in all patients who discontinued treatment, providing important reassurance for the predominantly young female patient population.

Tecentriq and Avastin Combination Now Funded for Advanced Liver Cancer in New Zealand

2 months ago

• Pharmac has approved public funding for Tecentriq (atezolizumab) in combination with bevacizumab for hepatocellular carcinoma (HCC) in New Zealand, benefiting approximately 70 patients diagnosed annually. • The immunotherapy combination has demonstrated a 34% reduction in risk of death, with half of patients surviving beyond 18 months, representing a significant improvement over previous treatment options. • Māori and Pacific populations are disproportionately affected by HCC due to higher prevalence of risk factors including Hepatitis B and C, with Māori patients 31% more likely to die from liver cancer than non-Māori.

FDA Issues Second Rejection for Rivoceranib/Camrelizumab Combination in Unresectable Liver Cancer

2 months ago

• The FDA has issued a second Complete Response Letter (CRL) for the rivoceranib/camrelizumab combination therapy for unresectable hepatocellular carcinoma, with no specific reasons disclosed for the rejection. • The combination showed significant clinical benefits in the phase 3 CARES-310 trial, including improved overall survival of 23.8 months versus 15.2 months with sorafenib, and higher response rates (26.8% vs 5.9%). • Despite promising efficacy data, manufacturing concerns have plagued the application process, with the initial CRL in May 2024 citing deficiencies related to camrelizumab's manufacturing site inspection.

FDA Breakthrough Therapy Status Emerges as Game-Changer for Oncology Drug Development

3 months ago

• FDA's Breakthrough Therapy designation offers accelerated approval pathways for promising oncology drugs, potentially reducing development timelines to just 3 years and extending patent life. • The new designation has shown particular promise in oncology, with the majority of the first 10 breakthrough approvals being cancer drugs, demonstrating significant market advantages over traditional orphan drug status. • Companies like Pharmacyclics and Genmab have seen immediate positive market response, with stock prices jumping 10-13% following breakthrough designation announcements for their cancer drugs.

CELESTIAL and COSMIC-312 Trials Shape Future of HCC Treatment Landscape

3 months ago

• CELESTIAL trial establishes cabozantinib as standard second and third-line treatment for HCC, demonstrating improved overall survival of 10.2 months vs 8.0 months with placebo. • COSMIC-312 trial shows mixed results with cabozantinib-atezolizumab combination, achieving PFS benefits but failing to meet OS endpoints in first-line HCC treatment. • New research initiatives explore innovative combinations including novel immune checkpoint inhibitors, radiation therapy, and emerging cellular therapies like GPC3-targeted CAR T-cells.

FDA-Approved Fotivda Dose Shows Superior Efficacy in Renal Cell Carcinoma Treatment

3 months ago

• Analysis of three phase 3 trials demonstrates that the FDA-approved 1.34mg dose of Fotivda delivers superior antitumor activity compared to reduced 0.89mg dose in renal cell carcinoma patients. • Higher Fotivda exposure correlates with improved progression-free survival, with patients in the highest exposure quartile achieving 9.7 months median PFS versus 5.6 months in the lowest quartile. • Study reveals comparable hypertension risk between doses, while combination therapy with Opdivo at lower Fotivda dose showed no additional benefits over standard monotherapy.

Nivolumab Plus Ipilimumab Shows Promise in Advanced Hepatocellular Carcinoma

4 months ago

• The combination of nivolumab and ipilimumab has shown significantly improved overall survival in patients with unresectable hepatocellular carcinoma (HCC). • The CheckMate 9DW trial demonstrated a median overall survival of 23.7 months with nivolumab/ipilimumab compared to 20.6 months with lenvatinib or sorafenib. • The combination therapy also resulted in a higher objective response rate of 36% versus 13% with lenvatinib/sorafenib, indicating better tumor control. • The FDA has accepted the application for nivolumab plus ipilimumab as a first-line treatment for unresectable HCC, with a decision expected by April 2025.

China Medical System's MG-K10 Advances in Phase III Trials for Multiple Inflammatory Conditions

4 months ago

China Medical System's novel anti-IL-4Rα antibody MG-K10 has entered Phase III clinical trials for atopic dermatitis, asthma, and prurigo nodularis. The drug, which demonstrated promising efficacy and safety in Phase II trials, targets a global market expected to reach US$28.7 billion by 2030, addressing significant unmet needs in inflammatory disease treatment.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

4 months ago

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

Toripalimab Approved in Australia for Nasopharyngeal Carcinoma

4 months ago

• Toripalimab, an anti-PD-1 monoclonal antibody, has been approved in Australia for the treatment of nasopharyngeal carcinoma (NPC). • The approval covers first-line treatment in combination with chemotherapy and as a single agent for recurrent or metastatic NPC after platinum-based chemotherapy. • This marks toripalimab as the first and only immuno-oncology treatment option available for NPC patients in Australia. • The approval was based on data from the JUPITER-02 and POLARIS-02 trials, demonstrating improved survival and antitumor activity.

BMS's Opdivo/Yervoy Combo Shows Survival Benefit in First-line Liver Cancer Treatment

4 months ago

Bristol-Myers Squibb's immunotherapy combination of Opdivo and Yervoy has demonstrated superior survival benefits in first-line hepatocellular carcinoma treatment, with FDA decision expected by April 2024. The therapy showed a 36% objective response rate compared to 13% for standard treatments, potentially offering a new option for patients with unresectable liver cancer.

Stereotactic Body Radiation May Improve Survival in Liver Cancer Subset

4 months ago

A study published in JAMA Oncology suggests that stereotactic body radiation therapy (SBRT) before Nexavar (sorafenib) treatment may improve overall survival in patients with locally advanced hepatocellular carcinoma (HCC), although the improvement was not statistically significant. The study highlights the potential benefits of combining SBRT with Nexavar, including improved progression-free survival and quality of life for some patients.

FDA Reviews Accelerated Approvals for Keytruda, Opdivo, and Tecentriq in Multiple Cancers

5 months ago

• The FDA is re-evaluating the accelerated approvals of Merck's Keytruda, Bristol-Myers Squibb's Opdivo, and Roche's Tecentriq across six cancer types due to failed confirmatory trials. • ODAC will discuss Tecentriq with Abraxane for advanced triple-negative breast cancer, focusing on alternative confirmatory studies after the Impassion131 trial failure. • Keytruda and Tecentriq's first-line treatment status for urothelial carcinoma is under review, considering the approval of Bavencio as a first-line maintenance therapy. • The committee will also assess Keytruda for gastric cancer and Keytruda/Opdivo for hepatocellular carcinoma, examining if the initial benefits have been confirmed.

Expert Outlines Patient-Specific Approach for IO Combinations in Unresectable HCC Treatment

5 months ago

• Recent FDA approvals of atezolizumab plus bevacizumab and durvalumab plus tremelimumab have transformed the first-line treatment landscape for unresectable hepatocellular carcinoma. • Treatment selection between immunotherapy combinations is primarily driven by patient-specific factors, with bleeding risk from bevacizumab being a key consideration for treatment choice. • While durvalumab plus lenvatinib offers an oral treatment option, its adverse effect profile and patient eligibility criteria overlap with existing combinations, limiting its first-line utility.

Mabgeek's MG-K10 Advances to Phase III Trials with Chime Biologics' Support

5 months ago

• Mabgeek's MG-K10, a humanized anti-IL-4Rα monoclonal antibody, has completed Process Performance Qualification (PPQ), advancing to Phase III trials. • The trials will target Th2-mediated inflammatory diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disease, and prurigo nodularis. • MG-K10 stands out as the only pipeline product with a verified once-every-four-week dosing schedule, potentially improving patient adherence. • Chime Biologics and Mabgeek's collaboration focuses on accelerating MG-K10's commercial manufacturing and development for global markets.

FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors

5 months ago

• The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo. • CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo. • Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients. • The approval helps Bristol Myers Squibb maintain market share amid patent expirations and increasing biosimilar competition.

Keytruda Approved in China for Early-Stage NSCLC Treatment

5 months ago

• Keytruda gains approval in China for resectable stage II, IIIA, or IIIB NSCLC in combination with platinum-containing chemotherapy. • The approval is based on the KEYNOTE-671 trial, demonstrating a significant improvement in overall survival and event-free survival. • This marks Keytruda's fourth indication for NSCLC in China, extending its use to earlier stages of the disease. • The treatment involves neoadjuvant Keytruda plus chemotherapy, followed by adjuvant Keytruda monotherapy post-surgery.

Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment

6 months ago

• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy. • The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough. • Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment. • Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.

Combination Therapies Reshape Frontline HCC Treatment Landscape

6 months ago

• Combination regimens, including STRIDE (single tremelimumab and regular-interval durvalumab), are transforming first-line HCC treatment, offering personalized options. • HIMALAYA trial's 5-year data showed STRIDE achieved a median OS of 16.43 months versus 13.77 months with sorafenib, marking the longest follow-up in unresectable HCC. • LEAP-012 study indicated that lenvatinib plus pembrolizumab and TACE improved median PFS to 14.6 months compared to 10.0 months with TACE alone. • Real-world data from the STELLAR trial supports the use of TKIs like lenvatinib for patients ineligible for or failing immunotherapy, showing manageable safety profiles.

Drug Development Updates