Tagged News
Pfizer Receives CDSCO Approval for Phase 3 Trial of HER2-Targeting ADC Disitamab Vedotin
• 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.
EL1SSAR Trial Confirms Efficacy of Atezolizumab Plus Nab-Paclitaxel in PD-L1-Positive Advanced TNBC
• The phase IIIb EL1SSAR trial demonstrates that atezolizumab plus nab-paclitaxel provides significant clinical benefit in PD-L1-positive advanced triple-negative breast cancer, with median overall survival reaching 27 months in the overall population.
• Patients with centrally confirmed PD-L1-positive tumors showed superior outcomes, with median progression-free survival of 11.1 months and overall survival not yet reached, highlighting the importance of accurate biomarker testing.
• The safety profile was consistent with previous findings from the IMpassion130 trial, with 47% of patients experiencing grade ≥3 adverse events and 12% developing grade ≥2 immune-mediated adverse events, with no treatment-related deaths reported.
Highlighted Clinical Trials:
Hoffmann-La Roche
Posted 12/17/2019
Eisai's Remitoro Clears Post-Marketing Surveillance Requirements for T-Cell Lymphoma Treatment in Japan
• Japan's Ministry of Health has lifted the all-case surveillance requirement for Eisai's anticancer agent Remitoro after reviewing safety data from 111 patients and efficacy data from 85 patients with T-cell lymphoma.
• Remitoro, a fusion protein combining IL-2 and diphtheria toxin, demonstrated an overall response rate of 16.5% across both peripheral and cutaneous T-cell lymphoma patients in the post-marketing study.
• Common adverse reactions included elevated liver enzymes (22.5%), capillary leak syndrome (21.6%), and decreased platelet count (15.3%), confirming the safety profile in real-world clinical settings.
AI in Oncology: Transforming Community Practice from Patient Care to Revenue Cycles
• AI adoption in oncology practices is rapidly growing, with current utilization at 40-50% and projected to reach 70-80% in the next few years, enhancing both clinical decision support and practice operations.
• AI technologies are improving patient care by facilitating education, reducing financial toxicity, streamlining practice connections, and helping clinicians manage the increasing complexity of precision medicine data.
• Community oncology practices need a pragmatic, strategic approach to AI implementation that prioritizes specific practice needs, workflow integration, and patient readiness to maximize benefits while addressing potential disparities.
FDA Advisory Committee Rejects UroGen's Bladder Cancer Therapy UGN-102
• UroGen Pharma's stock plummeted approximately 47% after an FDA advisory committee voted against its bladder cancer therapy UGN-102 (mitomycin), citing concerns over study design.
• The FDA had repeatedly recommended a randomized trial design, noting that the Envision trial's lack of a concurrent control arm made primary endpoints difficult to interpret.
• Despite UroGen reporting an 80.6% probability of patients remaining in complete response at 18 months, the regulatory setback highlights challenges in developing alternatives to surgical intervention for bladder cancer.
Landmark VA Study Reveals Genomic Differences in Metastatic Prostate Cancer Across Racial Groups
• Researchers from Moffitt Cancer Center and partners analyzed genomic data from over 5,000 veterans with metastatic prostate cancer, finding significant biological differences between non-Hispanic Black and white patients.
• Non-Hispanic Black veterans showed higher rates of genomic alterations associated with immunotherapy benefit, while white veterans had more frequent mutations in DNA repair genes and androgen receptor pathways.
• Despite these biological differences, both groups demonstrated similar survival outcomes when given equal access to care, highlighting the potential of precision oncology to reduce healthcare disparities.
Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing
• Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
• The biosimilar developer's strategic expansion includes acquiring Xbrane's R&D operations at the Karolinska life-science hub, strengthening its research capabilities and establishing a footprint in Sweden's biotech sector.
• Trading of Alvotech's SDRs on Nasdaq Stockholm commenced on May 19, 2025, under the ticker "ALVO SDB," enhancing the company's access to Nordic and European investors and capital markets.
Remedy Plan Therapeutics Secures $18 Million to Advance Novel NAMPT Inhibitor for AML and MDS Treatment
• Gaithersburg-based Remedy Plan Therapeutics has raised $18 million in an oversubscribed insider financing round, bringing their total funding to $55 million to date.
• The funding will accelerate the development of RPT1G, their first-in-class NAMPT inhibitor, into Phase 1/2 clinical trials for acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
• Remedy Plan's innovative "hyperbolic" approach to NAMPT inhibition avoids the on-target toxicities that have hindered previous development efforts, potentially addressing over 20 diseases spanning oncology, autoimmunity, and metabolic disorders.
Highlighted Clinical Trials:
Remedy Plan, Inc.
Posted 11/18/2024
Moderna Advances Oncology Pipeline with First Dosing in Phase 1 Trial of Novel mRNA Cancer Therapy
• Moderna has initiated dosing of mRNA-4106, an innovative cancer therapy candidate, in a Phase 1 clinical trial, marking a significant step in expanding its oncology pipeline beyond vaccines.
• The advancement comes amid financial challenges for the company, with analysts projecting continued negative earnings for the next three years despite the potential for new revenue streams.
• Despite a 3% stock decline last week contrary to broader market gains, analysts maintain a consensus price target of $46.96, suggesting potential upside if the company's oncology strategy proves successful.
Novartis Receives CDSCO Approval for Phase IIIb Trial of Asciminib in Chronic Myeloid Leukemia
• Novartis Healthcare has secured approval from India's CDSCO expert committee to conduct a Phase IIIb roll-over study of asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia.
• Asciminib (ABL001) functions as a novel allosteric inhibitor targeting the BCR-ABL1 kinase's myristoyl pocket, distinguishing it from traditional ATP-competitive tyrosine kinase inhibitors used in CML treatment.
• The multi-center, open-label study will assess long-term safety in patients who have completed previous Novartis-sponsored asciminib trials and are deemed to benefit from continued treatment.