PIK3CA

RWJBarnabas Health and Rutgers Cancer Institute to Present 45 Groundbreaking Studies at ASCO 2025

6 hours ago

• Researchers from RWJBarnabas Health and Rutgers Cancer Institute will showcase 45 innovative cancer studies at the 2025 ASCO Annual Meeting, highlighting advances across multiple tumor types and treatment approaches. • A notable multisite randomized trial demonstrated that problem-solving skills training significantly improved depression, anxiety, and quality of life in young adults newly diagnosed with cancer compared to standard care. • New research revealed that patients living in both food and clinical trial deserts had 27% lower likelihood of breast cancer trial enrollment, highlighting how geographic and socioeconomic barriers impact cancer care access.

Colorectal Cancer Leads in Real-World Data Volume, But Oncology Trials Need Modernization

8 days ago

• Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers. • Despite the wealth of available data, oncology clinical trials continue to suffer from inefficiencies, with trial design and execution failing to keep pace with advances in biomarker science and patient profiling. • Experts urge a shift toward "precision oncology" using AI and clinical data science to optimize patient profiles, programs, protocols, and operations plans to accelerate drug development.

Precision Medicine Breakthrough Shows 2.6-Fold Survival Improvement in Deadly Canine Cancer

9 days ago

• FidoCure and Stanford researchers have published groundbreaking findings showing targeted therapies significantly improve survival rates in dogs with splenic hemangiosarcoma, the deadliest canine cancer. • The study of 508 dogs revealed that precision medicine approaches led to a 1.8-fold improvement in median survival compared to surgery alone, increasing to 2.6-fold when combined with chemotherapy. • Researchers identified specific genetic mutations like NRAS that indicate less aggressive cancer subtypes, enabling more personalized treatment plans and potentially informing human angiosarcoma therapies.

AstraZeneca Halts Phase 3 Trial of Capivasertib for Metastatic Castration-Resistant Prostate Cancer

24 days ago

• AstraZeneca has discontinued the Phase 3 CAPItello-280 trial evaluating Truqap (capivasertib) plus docetaxel and ADT in metastatic castration-resistant prostate cancer after an independent monitoring committee determined the treatment was unlikely to meet primary endpoints. • The trial involved 1,033 patients and was designed to validate earlier promising results from the Phase 2 ProCAID trial, which had shown extended overall survival with capivasertib in patients who received prior androgen receptor-targeted therapy. • Despite the setback in prostate cancer, Truqap remains approved in multiple countries for HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific biomarker alterations following progression on endocrine-based regimens.

Breakthrough Breast Cancer Drug Capivasertib Approved for NHS Use

a month ago

• A groundbreaking twice-daily pill called capivasertib (Truqap) has been approved for NHS use, targeting hormone receptor-positive HER2-negative breast cancer by blocking cancer growth mechanisms. • Clinical trials demonstrated the drug extends time before cancer progression by over four months when used alongside hormone therapy Fulvestrant, offering new hope for approximately 3,000 women annually. • The treatment specifically benefits patients with PIK3CA, AKT1 or PTEN gene mutations, allowing many to maintain good quality of life with fewer debilitating side effects compared to other treatment regimens.

Novel BCMA-Directed CAR T-Cell Therapy Shows Promising Efficacy in Relapsed/Refractory Multiple Myeloma and AL Amyloidosis

2 months ago

• A second-generation BCMA-directed CAR T-cell therapy, MDC-CAR-BCMA001, demonstrated remarkable efficacy in patients with relapsed/refractory multiple myeloma and AL amyloidosis, achieving a 5/6 overall response rate with 4 complete responses. • The novel therapy showed a favorable safety profile with manageable toxicity, including low incidence of severe cytokine release syndrome and no neurotoxicity, even in patients with significant organ dysfunction. • These promising results have prompted further investigation through ongoing clinical trials, including CARLOTTA001 (NCT05836896) and the CLEAR AL trial, potentially offering new hope for difficult-to-treat hematologic malignancies.

Organ-Sparing TMLI with Post-Transplant Cyclophosphamide Shows Promising Results for AML Transplant Patients

2 months ago

• A novel approach combining total marrow and lymphoid irradiation (TMLI) at 20 Gy with post-transplant cyclophosphamide demonstrated remarkable outcomes in AML patients undergoing transplantation, with 84% overall survival at 2 years. • The targeted radiation technique successfully delivered higher doses to disease sites while sparing healthy organs, resulting in zero non-relapse mortality and no grade 3-4 toxicities among the 34 study participants. • All patients were able to discontinue immunosuppression therapy, addressing a major quality-of-life concern in transplantation, while maintaining low relapse rates of 15% at the 2-year follow-up.

Celldex Advances Barzolvolimab Phase 3 Program in Chronic Urticaria with Strong Pipeline Progress

3 months ago

• Celldex Therapeutics reports significant progress in Phase 3 trials of barzolvolimab for chronic spontaneous urticaria (CSU), with active enrollment ongoing across 40 countries and 500 sites. • The company's Phase 2 CSU study demonstrated unprecedented efficacy with 71% of patients achieving complete response at Week 52, setting a new standard in disease treatment. • Celldex expands its portfolio by initiating Phase 2 trials in atopic dermatitis and launching CDX-622, their first bispecific antibody targeting inflammatory diseases.

Cost and Implementation Barriers Challenge Adoption of Novel mUC Therapies, ASCO GU Studies Show

3 months ago

• New cost-effectiveness analysis reveals gemcitabine-cisplatin plus nivolumab as more economically viable than enfortumab-vedotin plus pembrolizumab for metastatic urothelial carcinoma treatment in Europe. • Healthcare providers face significant challenges in implementing new mUC therapies, with 28% struggling with treatment sequencing and 24% finding it difficult to keep pace with clinical evidence. • Survey shows only 45% of cisplatin-ineligible patients receive FDA-approved first-line immunotherapy combinations, highlighting the gap between available treatments and clinical practice.

Inventiva Restructures to Focus on MASH Drug Development, Reports €96.6M Year-End Cash Position

3 months ago

• Inventiva announces strategic pipeline prioritization, halting all preclinical research to focus exclusively on lanifibranor development for MASH treatment, with planned 50% workforce reduction. • Company reports €96.6 million cash position at 2024 year-end, securing operations until Q3 2025, with potential additional funding of €116 million expected in Q2 2025. • Last patient screening completed in NATiV3 Phase 3 trial of lanifibranor, with final patient randomization expected in first half of 2025 and topline results anticipated in second half of 2026.

Targeted Therapies and Immunotherapy Advances in Non-Small Cell Lung Cancer: A Comprehensive Review

3 months ago

• Targeted therapies for NSCLC have revolutionized treatment for patients with specific genetic alterations, with EGFR, ALK, and ROS1 inhibitors showing significant improvements in progression-free survival compared to traditional chemotherapy. • Immunotherapy, particularly immune checkpoint inhibitors targeting PD-1/PD-L1 and CTLA-4, has become a cornerstone in NSCLC treatment, with newer targets like LAG-3, TIM-3, and TIGIT showing promise in ongoing clinical trials. • Advanced cellular therapies including adoptive cell transfer, CAR-T cells, and cancer vaccines represent the next frontier in NSCLC treatment, particularly for patients with "cold tumors" who don't respond to standard immunotherapies.

Personalized Cancer Vaccine Shows Promising Results in Advanced Kidney Cancer Trial

4 months ago

• A groundbreaking Phase 1 trial at Yale Cancer Center demonstrated successful anti-cancer immune responses in all nine patients with advanced kidney cancer using personalized therapeutic vaccines. • The vaccine, designed to target specific tumor mutations, generated strong T-cell responses within three weeks of treatment and maintained effectiveness for approximately three years post-treatment. • Patients experienced minimal side effects, primarily mild flu-like symptoms, suggesting a favorable safety profile for this innovative approach to treating advanced clear cell renal cell carcinoma.

Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression

4 months ago

• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. • Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. • Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. • Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.

T-DXd Shows Promise in HER2-Ultra Low Breast Cancer, Expanding Treatment Horizons

4 months ago

• DESTINY-Breast06 trial demonstrates significant progression-free survival benefit of T-DXd in HER2-low and ultra-low breast cancer patients, with 13.2 vs 8.1 months compared to standard chemotherapy. • New data suggests T-DXd's efficacy may extend beyond traditional HER2 expression levels, potentially benefiting patients previously considered HER2-negative (IHC 0). • Clinical evidence supports earlier integration of T-DXd in treatment sequencing for HR-positive breast cancer patients, though formal approval for ultra-low expression is pending.

Aspirin Reduces Colorectal Cancer Recurrence in PI3K-Mutated Tumors

4 months ago

• A daily 160mg dose of aspirin significantly reduces the risk of colorectal cancer recurrence in patients with PI3K mutations. • The ALASCCA trial demonstrated a 51% to 58% reduction in recurrence risk in patients with specific PI3K pathway alterations. • The study highlights the potential for repurposing aspirin as a cost-effective adjuvant therapy and emphasizes the importance of genomic testing. • While aspirin was generally safe, the study reported a slightly higher incidence of adverse events compared to placebo.

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.

Novel HER2-Targeted Therapies Show Promise in Overcoming Treatment Resistance in Advanced Breast Cancer

4 months ago

• New HER2-directed antibody-drug conjugate SHR-A1811 demonstrates impressive 76.3% response rate in HER2-positive breast cancer patients, with potentially improved safety profile compared to existing treatments. • Bispecific antibody zanidatamab combined with evorpacept shows 55.6% response rate in heavily pretreated patients who progressed on T-DXd, offering hope for resistant disease. • Research reveals potential resistance mechanisms to HER2-targeted therapies, including topoisomerase I alterations and HER2 gene loss, helping guide future treatment strategies.

FDA Approvals in 2024: Advancing Treatment Paradigms in Solid Tumors and Hematologic Malignancies

5 months ago

• The FDA granted over 65 approvals in 2024, significantly impacting treatment paradigms across various cancers, including breast, gynecologic, skin, and genitourinary malignancies. • Several tumor-agnostic approvals, such as fam-trastuzumab deruxtecan-nxki (Enhertu) for HER2-positive solid tumors and repotrectinib (Augtyro) for NTRK fusion-positive tumors, marked advancements in precision medicine. • Immunotherapies like nivolumab (Opdivo) and pembrolizumab (Keytruda) received multiple approvals, including combinations with chemotherapy for urothelial and endometrial carcinomas, improving patient outcomes. • Targeted therapies like vorasidenib (Voranigo) for low-grade glioma and selpercatinib (Retevmo) for RET-mutated thyroid cancers addressed unmet needs and demonstrated high efficacy and tolerability.

Experts Highlight Advances in Lung Cancer Treatment: Immunotherapy, ADCs, and Equity in Care

5 months ago

• Leading oncologists at the Chicago IVBM event discussed the transformation of lung cancer treatment, emphasizing the evolution of immunotherapy from second-line to first-line and early-stage treatments. • Experts addressed emerging technologies including antibody-drug conjugates like trastuzumab deruxtecan, highlighting significant progression-free survival benefits in second-line settings. • The panel identified critical challenges in healthcare equity, calling for standardized molecular testing protocols and enhanced collaboration between academic centers and community providers.

ctDNA Testing Shows Promise in Guiding Breast Cancer Treatment Decisions

5 months ago

• A study reveals ctDNA analysis offers a deeper understanding of the genetic makeup of advanced breast cancer, enabling more personalized treatment approaches. • ctDNA testing influenced treatment decisions in 35% of advanced breast cancer cases, potentially improving outcomes and reducing resistance. • Baseline ctDNA levels correlate with tumor size and endocrine therapy sensitivity in HR-positive early breast cancer, according to the PELOPS trial. • Ultra-sensitive ctDNA testing may predict long-term outcomes and guide systemic treatment decisions in early breast cancer, warranting further investigation.

Drug Development Updates