Disitamab vedotin

Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug

3 days ago

• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones. • SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year. • The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.

Pfizer Receives CDSCO Approval for Phase 3 Trial of HER2-Targeting ADC Disitamab Vedotin

5 days ago

• India's CDSCO expert panel has granted Pfizer conditional approval to conduct Phase 3 clinical trials of Disitamab Vedotin, an antibody-drug conjugate targeting HER2-positive solid tumors. • The approval requires Pfizer to include more geographically distributed government sites across India and mandates that principal investigators must be medical oncologists. • Disitamab Vedotin (RC48) combines a HER2-targeting monoclonal antibody with cytotoxic agent monomethyl auristatin E (MMAE), showing promise for gastric and urothelial cancers.

China Approves Remegen's Disitamab Vedotin for HER2-Positive Advanced Breast Cancer with Liver Metastasis

9 days ago

• China's National Medical Products Administration (NMPA) has approved Remegen's antibody-drug conjugate disitamab vedotin (RC-48) for patients with HER2-positive advanced breast cancer with liver metastasis. • The approval marks a significant advancement in targeted therapy options for Chinese patients with advanced breast cancer, particularly addressing the challenging subset with liver metastases. • Disitamab vedotin joins the growing field of antibody-drug conjugates targeting HER2, offering a new treatment approach in a market where targeted therapies for metastatic breast cancer remain an area of high unmet need.

Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion

13 days ago

• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities. • The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake. • This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.

Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options. • Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab. • Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.

Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy

3 months ago

• Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes. • The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate. • The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.

DelveInsight Report: Over 50 Pipeline Drugs in Development for Urothelial Carcinoma Treatment

4 months ago

• DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space. • Major pharmaceutical companies including AstraZeneca, Seagen, and Janssen are advancing promising therapies, with notable candidates like disitamab vedotin and cetrelimab in late-stage development. • Recent clinical trials include Seagen's Phase 2 study of disitamab vedotin with pembrolizumab, and Roche's Phase 1b/II umbrella study investigating multiple combination therapies for advanced urothelial carcinoma.

Seagen Secures $2.6B Deal with RemeGen for Novel HER2-Targeting Cancer Drug

4 months ago

• Seagen has entered a $2.6 billion licensing agreement with Chinese biotech RemeGen for disitamab vedotin, a HER2-targeting antibody-drug conjugate, with $200 million paid upfront. • The drug has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer. • This strategic move positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla in multiple cancer indications.

Pfizer to Present Landmark Survival Data for Cancer Therapies at ASCO GU 2025 Symposium

4 months ago

• Pfizer will showcase over 20 abstracts at ASCO GU 2025, including pivotal Phase 3 TALAPRO-2 trial results demonstrating significant overall survival benefits for TALZENNA-XTANDI combination in prostate cancer. • Updated analysis from Phase 3 EV-302 trial confirms sustained survival advantage of PADCEV with pembrolizumab in advanced urothelial cancer, reinforcing its position as a first-line treatment standard. • Novel investigational therapy mevrometostat shows promising progression-free survival data when combined with XTANDI in metastatic castration-resistant prostate cancer, advancing Pfizer's genitourinary cancer pipeline.

Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations

4 months ago

• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy. • Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities. • Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease. • The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.

J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

4 months ago

• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200. • TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC). • Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy. • The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.

Disitamab Vedotin and Toripalimab Show Promising Results in Urothelial Carcinoma Treatment

4 months ago

A phase 1b/2 clinical trial reveals that the combination of disitamab vedotin and toripalimab offers encouraging efficacy and a manageable safety profile for patients with locally advanced or metastatic urothelial carcinoma, with a confirmed objective response rate of 73.2%.

Advancements in Breast Cancer Research Unveiled at SABCS 2024

5 months ago

• The PATINA trial suggests palbociclib with anti-HER2 and endocrine therapy may become a new standard for HR+, HER2+ metastatic breast cancer. • COMET trial indicates active monitoring is comparable to surgery for low-risk DCIS, offering a potential alternative management option. • OlympiA trial's long-term results reinforce olaparib's role in preventing recurrence and highlight the importance of BRCA testing for early-stage breast cancer.

Disitamab Vedotin Shows Promise in HER2-Positive Breast Cancer with Liver Metastasis

5 months ago

• Disitamab Vedotin (DV) significantly improved progression-free survival (PFS) compared to Lapatinib plus Capecitabine in HER2-positive advanced breast cancer with liver metastasis. • The Phase III study (RC48-C006) is the first global prospective, randomized trial demonstrating the efficacy of a HER2-targeting ADC in this patient population. • DV demonstrated a manageable safety profile, consistent with previous experience, offering a potential new treatment option for previously treated patients. • The Biologics License Application for Disitamab Vedotin has been accepted and granted priority review by China's National Medical Products Administration.

Disitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer

5 months ago

• Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC). • Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%. • The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population. • Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.

Disitamab Vedotin Shows Promising Activity in HER2-Expressing Metastatic Breast Cancer with PAM Pathway Abnormalities

6 months ago

• Disitamab vedotin (RC48) demonstrates an objective response rate of 34.4% in HER2-expressing metastatic breast cancer patients with abnormal PAM pathway activation. • The disease control rate with disitamab vedotin was 81.97% across all HER2-expressing metastatic breast cancer patients in the phase 2 trial. • Median progression-free survival was 3.5 months in all patients, with no significant difference between HER2-positive and HER2-low subgroups. • The safety profile of disitamab vedotin was manageable, with most adverse events being grade 1 or 2, and no treatment-related deaths reported.

Emerging Intravesical and Systemic Therapies Revolutionize Bladder Cancer Treatment

6 months ago

• Intravesical therapies like cretostimogene and TAR-200 show promising complete response rates in BCG-unresponsive NMIBC, but duration of response remains a key factor. • Perioperative systemic therapies, including neoadjuvant chemo-immunotherapy with durvalumab, aim to improve event-free and overall survival in muscle-invasive urothelial carcinoma. • Antibody-drug conjugates (ADCs) targeting Nectin-4 and HER2, such as enfortumab vedotin and disitamab vedotin, demonstrate significant potential in metastatic urothelial cancer. • Novel strategies, including dual-targeting antibodies and combinations of ADCs with immunotherapies, are being explored to further enhance treatment efficacy and overcome resistance.

Prevalence and Profiles of Treatment-Related Adverse Events in Metastatic Breast Cancer Patients Receiving Antibody-Drug Conjugates

6 months ago

A meta-analysis of 23 clinical trials reveals the prevalence and distinct toxicity profiles of treatment-related adverse events (TRAEs) associated with currently approved antibody-drug conjugates (ADCs) for metastatic breast cancer. Gastrointestinal disorders were highly prevalent across all treatments, with Trastuzumab Deruxtecan and Sacituzumab Govitecan showing higher symptom burdens compared to Trastuzumab Emtansine. The study underscores the importance of understanding these TRAEs to enhance supportive care and develop personalized risk-stratified care pathways.

Zelenectide Pevedotin Shows Promise in Urothelial Carcinoma Treatment

8 months ago

• Zelenectide pevedotin, a novel bicycle toxin conjugate, targets Nectin-4 and is being evaluated for metastatic urothelial carcinoma. • Early data from the Duravelo-1 trial show a 45% objective response rate in patients who had not received enfortumab vedotin. • The ongoing Duravelo-2 trial is assessing zelenectide pevedotin as monotherapy and in combination with pembrolizumab. • Researchers hope zelenectide pevedotin will offer a less toxic alternative to existing Nectin-4 targeted therapies.

Disitamab Vedotin Plus Pembrolizumab Shows Promise in HER2-Expressing Urothelial Cancer

8 months ago

• Disitamab vedotin combined with pembrolizumab demonstrates a 75% response rate in treatment-naive metastatic urothelial cancer patients with HER2 expression. • The combination shows activity in both HER2-positive and HER2-low tumors, suggesting a broad potential application in urothelial cancer. • The safety profile of disitamab vedotin plus pembrolizumab differs from enfortumab vedotin plus pembrolizumab, potentially offering a distinguishing factor. • An international phase III study is underway, comparing the combination to platinum-based chemotherapy to further evaluate its efficacy.

Disitamab vedotin

Drug Development Updates