Nivolumab Plus AVD Emerges as New Standard for Advanced Hodgkin Lymphoma Treatment
• Phase 3 SWOG S1826 trial demonstrates superior efficacy of nivolumab combined with AVD compared to brentuximab vedotin plus AVD in advanced-stage classic Hodgkin lymphoma.
• The nivolumab-AVD combination showed better tolerability with no new safety signals, establishing itself as a new standard of care for advanced-stage Hodgkin lymphoma patients.
• Clinical findings indicate improved treatment outcomes with N+AVD, marking a significant advancement in the therapeutic landscape for stage III and IV Hodgkin lymphoma.
Immune Biomarkers Show Promise in Guiding TNBC Treatment Decisions
• High levels of tumor-infiltrating lymphocytes (TILs) strongly correlate with improved survival in triple-negative breast cancer patients, with 94% 5-year survival rates observed in patients with TIL levels ≥50%.
• Studies demonstrate that TNBC tumors with elevated TIL levels respond favorably to immunotherapy, with pembrolizumab showing superior outcomes in high-TIL patients compared to chemotherapy.
• Beyond TILs, emerging biomarkers including MHC-II expression, tumor mutational burden, and B-cell markers show potential for optimizing immunotherapy patient selection in TNBC treatment.
Real-World AVION Study Affirms Avelumab Plus Axitinib Efficacy in Advanced Renal Cell Carcinoma
• The AVION study demonstrated that first-line avelumab plus axitinib is effective and safe for advanced renal cell carcinoma (RCC) in real-world settings.
• The 12-month overall survival rate was 82.7% among patients receiving the combination therapy, aligning with results from prior clinical trials.
• Common treatment-related adverse events included diarrhea, fatigue, and hypertension, with manageable safety profiles and stable health-related quality of life.
• These findings support the use of avelumab plus axitinib as a frontline treatment option for advanced RCC, reinforcing its clinical benefit.
Pfizer's Braftovi Combo Shows Survival Benefit in BRAF-Mutated Metastatic Colorectal Cancer
• Pfizer's Braftovi, combined with cetuximab and mFOLFOX6, significantly improved progression-free survival in metastatic colorectal cancer patients with BRAF V600E mutation.
• The BREAKWATER trial demonstrated a clinically meaningful improvement in overall survival with the Braftovi regimen compared to chemotherapy.
• The FDA granted accelerated approval to the Braftovi combination in December 2024, marking it as a first-line targeted therapy option.
• Pfizer plans to share the BREAKWATER data with regulatory authorities to support full approval and broader use of the Braftovi combination.
ASH 2024: Updates on Daratumumab, Selinexor, and Asciminib Highlighted
• Long-term follow-up data from the phase 3 AQUILA study will explore daratumumab monotherapy's efficacy in delaying progression in high-risk smoldering multiple myeloma.
• Updated results from the phase 1b/2 STOMP trial will present 96-week data on selinexor plus pomalidomide and dexamethasone in multiple myeloma.
• The ASH meeting will feature a 96-week data update from the phase 3 ASC4FIRST trial, assessing asciminib as a first-line treatment for CML-CP.
Detalimogene Voraplasmid and Gemcitabine Combinations Show Promise in Bladder Cancer Trials
• Detalimogene voraplasmid (EG-70) shows a 71% any-time complete response rate in BCG-unresponsive NMIBC patients with carcinoma in situ in the LEGEND trial.
• Gemcitabine and docetaxel combination demonstrates a 92% complete response rate at 12 months in BCG-naive, high-risk NMIBC patients.
• Gemcitabine-BCG combination shows a 94% complete response rate at 6 months in BCG-exposed NMIBC, suggesting enhanced efficacy and safety.
• Studies highlight the potential of novel intravesical therapies to improve outcomes and reduce the need for radical cystectomy in bladder cancer.
P-BCMA-ALLO1 Demonstrates Promising Efficacy and Safety in Relapsed/Refractory Multiple Myeloma
• P-BCMA-ALLO1, an allogeneic CAR-T therapy, shows an 88% overall response rate in relapsed/refractory multiple myeloma patients in a phase 1/1b trial.
• The therapy demonstrates a 100% ORR in BCMA-naive patients and a 75% ORR in those previously treated with BCMA-targeted therapies.
• No grade 3 or higher cytokine release syndrome or neurotoxicity was observed, indicating a favorable safety profile for P-BCMA-ALLO1.
• P-BCMA-ALLO1 offers a readily available, off-the-shelf treatment option, eliminating the wait time associated with autologous CAR-T therapies.
ESMO and ASTRO 2024: Advances in Prostate and Bladder Cancer Treatment
• ESMO 2024 highlighted transdermal estradiol as a non-inferior alternative to LHRH analogs for non-metastatic prostate cancer, reducing hot flashes but increasing gynecomastia.
• The ARANOTE trial demonstrated that darolutamide combined with ADT significantly improved rPFS in metastatic hormone-sensitive prostate cancer, with manageable side effects.
• ASTRO 2024 presentations emphasized personalized radiotherapy approaches for bladder cancer and innovative uses of radiotherapy in oligometastatic prostate cancer.
ESMO 2024: Key Prostate Cancer Advances Highlighted
• Transdermal estradiol shows non-inferiority to LHRH analogs in metastasis-free survival for non-metastatic prostate cancer, offering a potential alternative with fewer metabolic side effects.
• Darolutamide plus ADT significantly improves rPFS in metastatic hormone-sensitive prostate cancer, with a favorable safety profile, though overall survival data is still pending.
• Metformin improves metabolic parameters in prostate cancer patients but does not significantly impact overall survival, suggesting a potential role in managing treatment-related metabolic adverse events.
• Radium-223 plus enzalutamide demonstrates improved rPFS in metastatic castration-resistant prostate cancer with bone metastases, positioning it as a potential new standard of care.
Nivolumab Plus Ipilimumab Shows Durable Survival Benefit in Advanced RCC
• Eight-year data from CheckMate 214 show nivolumab plus ipilimumab demonstrates long-term efficacy in intermediate- and poor-risk advanced renal cell carcinoma (RCC).
• In favorable-risk patients, nivolumab plus ipilimumab shows a hazard ratio of 0.82, surpassing historical IO-TKI trial results, suggesting its viability in this group.
• IO-TKI combinations are beneficial for patients needing rapid response due to high disease burden, while IO-IO combinations offer potential for long-term disease control.
• Ongoing trials are exploring novel targets like HIF2α inhibitors to overcome resistance to immune checkpoint inhibition in RCC management.
ESMO 2024: Key Advances in Kidney and Bladder Cancer Treatment
• The TiNivo-2 study suggests that sequencing checkpoint inhibitors in advanced kidney cancer does not provide additional benefits, supporting TKI monotherapy after progression.
• SUNNIFORECAST trial data indicates that ipilimumab plus nivolumab could be a valid treatment option for advanced non-clear cell metastatic renal cell carcinoma.
• NIAGARA study results show that neoadjuvant chemotherapy combined with durvalumab improves event-free and overall survival in muscle-invasive bladder cancer.
• The SunRISe-4 trial explores TAR-200 in combination with cetrelimab as a potential alternative for cisplatin-ineligible patients with muscle-invasive bladder cancer.
Experts Highlight Critical Treatment Gaps in Metastatic Colorectal Cancer Management
• Despite FDA approval of cetuximab plus encorafenib for BRAF V600E-mutated mCRC, significant challenges remain in treating patients who progress after BRAF inhibitor therapy.
• The recent approval of adagrasib with cetuximab for KRAS G12C-mutated mCRC marks progress, but treatment options for other KRAS mutations remain limited, spurring interest in pan-RAS inhibitors.
• Refractory mCRC patients without actionable mutations face limited treatment options, emphasizing the crucial role of clinical trials in advancing therapeutic development.
Cilta-cel Demonstrates Sustained Survival Benefit in Pretreated Multiple Myeloma
• Updated data from the CARTITUDE-4 trial shows cilta-cel significantly improves overall survival in lenalidomide-refractory multiple myeloma patients compared to standard of care.
• At 33.6 months follow-up, the 30-month overall survival rate with cilta-cel was 76.4% versus 63.8% with standard of care, reducing the risk of death by 45%.
• The progression-free survival rate at 30 months was 59.4% with cilta-cel compared to 25.7% with standard of care, indicating a 71% reduction in disease progression or death.
• Cilta-cel also demonstrated high overall response rates (84.6%) and minimal residual disease negativity, highlighting its potential to transform the myeloma treatment landscape.
Kisqali and Itovebi Secure FDA Approval for Advanced Breast Cancer Treatment
• Ribociclib (Kisqali) gains FDA approval in combination with aromatase inhibitors for adjuvant treatment of HR+/HER2- early breast cancer, reducing recurrence risk.
• Inavolisib (Itovebi) receives FDA approval when combined with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
• The approvals offer new treatment options for a broader range of breast cancer patients, addressing unmet needs and improving care approaches.
Belzutifan Shows Durable PFS and ORR in Advanced Clear Cell RCC
• Belzutifan maintained improved progression-free survival (PFS) and objective response rate (ORR) compared to everolimus in previously treated advanced clear cell RCC.
• The median PFS was 5.6 months with belzutifan vs 5.6 months with everolimus; however, belzutifan did not outperform everolimus in overall survival (OS).
• Belzutifan led to a higher ORR than everolimus (22.7% vs 3.5%), with durable responses lasting over two years in some patients.
• The safety profile of belzutifan was comparable to everolimus, with most treatment-related adverse events having a quick onset.
NCCN Announces Projects to Study Oral Decitabine and Cedazuridine
The National Comprehensive Cancer Network (NCCN) Oncology Research Program has selected three projects to study the combination of oral decitabine and cedazuridine, aiming to explore its potential in tumor suppression. The studies, funded by Taiho Oncology, will commence in 2021 and focus on various cancer treatments, including AML relapse, androgen pathway inhibitors, and immune checkpoint blockade in melanoma.
Ibrutinib Shows Promise in Treating Chronic Graft-Versus-Host Disease
A study reveals that Ibrutinib, a Bruton tyrosine kinase inhibitor, has shown significant efficacy in treating chronic graft-versus-host disease (cGVHD) in patients who have failed corticosteroid therapy, with a high rate of sustained responses and acceptable safety profile.
© Copyright 2025. All Rights Reserved by MedPath