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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.
NCT06667765Active, Not RecruitingPhase 1
Remedy Plan, Inc.
Posted 11/18/2024

Revolution Medicines Advances First-in-Class KRAS(G12D) Molecular Glue Inhibitor RMC-9805 with Novel Cyclophilin A Mechanism

  • Revolution Medicines has developed RMC-9805, a first-in-class covalent KRAS(G12D)(ON) molecular glue inhibitor that targets the previously "undruggable" KRAS(G12D) mutant using a cyclophilin A-recruiting tricomplex mechanism.
  • The compound employs a finely tuned aziridine covalent handle to engage a poorly nucleophilic mutant Asp residue, representing a breakthrough in targeting this challenging oncogenic mutation.
  • Preclinical data presented at AACR 2024 demonstrated that RMC-9805 synergizes with PD-1 inhibitors, and the compound is making progress in clinical development.
  • The discovery leveraged structural and modeling insights to overcome the technical challenges of inhibiting KRAS(G12D), which has been considered one of the most difficult cancer targets to drug.

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.

ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer

  • The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
  • Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
  • ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.

Skin Cancer Awareness Month: Multimodal Approaches and Prevention Strategies Highlighted by Experts

  • Approximately 90% of skin cancers are preventable, with limiting sun exposure in the first 20 years of life being crucial as most lifetime UV damage occurs by age 20.
  • Advancements in skin cancer treatment include immunotherapy for metastatic melanoma, targeted agents for large basal cell cancers, and multimodality approaches where specialists collaborate on complex cases.
  • Radiation therapy remains an underutilized option for elderly or frail patients with skin cancer, particularly in cases where surgery might cause functional or structural damage.

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