Oggi in Oncologia
A Phase 1b/2 Study of Atezolizumab with or Without Bacille Calmette-Guérin in Patients with High-risk Non-muscle-invasive Bladder Cancer
Background: Bacille Calmette-Guérin (BCG) is the standard therapy after transurethral resection of bladder tumour for high-risk non-muscle-invasive bladder cancer (NMIBC). However, post-BCG recurrence/progression occurs frequently, and noncystectomy options are limited. Objective: To evaluate the safety and clinical activity of atezolizumab ± BCG in high-risk BCG-unresponsive NMIBC … (leggi tutto)
Lo studio open label di fase 1b/2 GU-123 ha incluso pazienti affetti da carcinoma uroteliale non muscolo-infiltrante della vescica (CIS con o senza Ta/T1 concomitante) non responsivi al Bacille Calmette-Guérin (BCG). Erano consentite istologie miste, purché vi fosse una componente uroteliale per almeno il 50%. La definizione di non responsività al BCG includeva: persistenza di CIS ad alto grado 6 mesi dopo il trattamento con BCG, progressione a 3 mesi dopo l’induzione col BCG, o CIS di alto grado ricorrente dopo un periodo libero da malattia inferiore a 6 mesi dall’ultima somministrazione di BCG. Inman et al. hanno riportato i dati delle coorti 1A e 1B, che includeva pazienti trattati, rispettivamente, con atezolizumab (1200 mg ogni 3 settimane per 2 anni) e atezolizumab + BCG (induzione + mantenimento).
Lo studio aveva come co-primary endpoint la sicurezza e il tasso di risposta completa a 6 mesi. Tra gli endpoint secondari, vi erano il tasso di risposta completa a 3 mesi e la durata della risposta completa.
Sono stati inclusi in totale 24 pazienti (12 per coorte).
Nella coorte 1B, 4 pazienti (33%) hanno sviluppato un evento avverso che ha richiesto la modifica di dose o interruzione del BCG, ma nessun evento avverso di grado 3 o superiore. Nella coorte 1A, il 25% dei pazienti (3/12) ha sviluppato un evento avverso di grado 3. Nella coorte 1A, il tasso di risposta completa a 6 mesi è stato del 33% con una durata mediana della risposta di 6.8 mesi. Nella coorte 1B, il tasso di risposta completa a 6 mesi è stato del 42% con una durata mediana non raggiunta.
Nella malattia non muscolo-infiltrante, la resistenza al BCG è stata associata all’espressione di PD-L1. Questo può costituire un razionale per l’utilizzo di inibitori dei checkpoint immunitari, al fine di ripristinare una immunità antitumorale altrimenti soppressa in pazienti non responsivi al BCG.
Il GU-123 costituisce il primo report di sicurezza ed efficacia della combinazione di atezolizumab + BCG nel carcinoma non muscolo-infiltrante della vescica: il trattamento risulta ben tollerato, senza particolari warning sulla sicurezza né morti tossiche. I risultati preliminari suggeriscono, inoltre, un’attività clinica significativa, giacché la combinazione ha favorito una durata più lunga della risposta aprendo così la strada ad ulteriori studi.
Pembrolizumab plus lenvatinib as first-line therapy for advanced non-clear-cell renal cell carcinoma (KEYNOTE-B61): a single-arm, multicentre, phase 2 trial
Background: Immunotherapy-based combinations including pembrolizumab plus lenvatinib are the standard of care for patients with first-line clear-cell renal cell carcinoma, but these combinations are not well characterised in non-clear-cell renal cell carcinoma. We aimed to assess the activity and safety of pembrolizumab plus lenvatinib as a first-line treatment for patients with advanced non-clear-cell renal cell carcinoma … (leggi tutto)
Lo studio di fase II a singolo braccio KEYNOTE-B61 è il companion dello studio CLEAR, che aveva valutato la combinazione di pembrolizumab e lenvatinib come trattamento frontline nell’istologia a cellule chiare. Nello studio di Albiges et al., sono stati arruolati 158 pazienti affetti da carcinoma renale con istologia non a cellule chiare in stadio IV non pre-trattati.
I pazienti inclusi hanno ricevuto in prima linea la combinazione di pembrolizumab 400 mg ogni sei settimane (per un massimo di due anni) più lenvatinib 20 mg/die fino a progressione, tossicità inaccettabile o ritiro del consenso.
Lo studio aveva il tasso di risposta obiettiva come endpoint primario. Dopo un follow up mediano di 14.9 mesi, il tasso di risposta obiettiva è stato del 49%, e 9 pazienti hanno ottenuto una risposta completa (6%), mentre nel 44% dei casi si è registrata una risposta parziale.
Il 51% dei pazienti ha riportato un evento avverso di grado 3-4, più frequentemente ipertensione, proteinuria e stomatite. Eventi avversi severi si sono presentati nel 20% dei pazienti, con 8 casi di morte.
Il punto di forza di questo trial è quello di essere uno dei più ampi in termini di numerosità campionaria attualmente disponibili per il carcinoma renale non a cellule chiare. Questo studio offre pertanto una buona overview su questa neoplasia relativamente eterogenea, in termini di varietà istologiche, applicazione di score prognostici e persino trattamenti approvati. Attualmente, tuttavia, una tra le principali criticità in questo setting è rappresentata dalla disponibilità unicamente di studi a singolo braccio. Anche se le risposte obiettive sono simili nelle varie istologie, queste potrebbero rappresentare popolazioni non sovrapponibili. Comprendere il grado di sovrapposizione o differenza diventerà un punto critico per gli sviluppi terapeutici futuri di questa patologia.
In Europa
Adjuvant mRNA-4157 Plus Pembrolizumab Prolongs RFS versus Pembrolizumab Alone in Patients with Resected High-Risk Melanoma
Jan 23, 2024 – mRNA-based individualised neoantigen therapy added to PD-1 blockade might provide increased clinical benefit in the adjuvant treatment of high-risk resected melanoma compared with PD-1 blockade alone according to the results from an open-label, randomised, phase IIb, adjuvant study of mRNA-4157 plus pembrolizumab versus pembrolizumab monotherapy conducted in patients with completely resected high-risk cutaneous melanoma … (leggi tutto)
Neoadjuvant Histotype-Tailored Treatment with Trabectedin Not Inferior to Standard Chemotherapy with Anthracycline Plus Ifosfamide in High-Grade Myxoid Liposarcoma
Jan 22, 2024 – In an expanded cohort of patients with primary localised high-grade myxoid liposarcoma of the extremities and trunk wall from a phase III randomised study that compared different regimens of neoadjuvant chemotherapy, disease-free survival (DFS) of patients in the trabectedin neoadjuvant arm was not inferior to the DFS of those in the neoadjuvant anthracycline plus ifosfamide chemotherapy arm ... (leggi tutto)
Proof of Concept for the Safety and Immunogenicity of Lymph Node Targeting KRAS Mutation Specific Amphiphile Vaccine and Promising Signal of Clinical Activity
Jan 18, 2024 – In a first-in-human phase I study, the AMPLIFY-201 researchers demonstrated that lymph node directed ELI-002 2P vaccination targeting KRAS driver oncogenes present in one-quarter of solid tumours is immunogenic in 84% of patients with minimal residual disease (MRD)-positive relapse after locoregional treatment. T cell responses required no selected human leukocyte antigen (HLA) patient restrictions and correlated with reduction ... (leggi tutto)
EMA Recommends Granting a Marketing Authorisation for Pomalidomide Viatris
Jan 17, 2024 – On 14 December 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Pomalidomide Viatris (pomalidomide), intended for treatment of multiple myeloma. The applicant for this medicinal product is Viatris Limited.… (leggi tutto)
Dall’FDA
FDA Approves Erdafitinib for FGFR3+ Locally Advanced or Metastatic Urothelial Carcinoma
Jan 19, 2024 – The FDA has approved erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations, as determined by an FDA-approved test, whose disease has progressed on or following at least 1 prior line of systemic therapy. The agent is not recommended for those who are candidates to receive and have not yet received PD-1/PD-L1 therapy, according to the regulatory agency … (leggi tutto)
FDA Grants Orphan Drug Designation to PTX-252 for AML
Jan 19, 2024 – The FDA has granted an orphan drug designation to PTX-252 for the treatment of patients with acute myeloid leukemia (AML), according to an announcement from Hyloris Pharmaceuticals. PTX-252 is designed to improve the responsiveness of cancer cells to chemotherapy with a novel molecular entity derived from an established molecule … (leggi tutto)
FDA Roundup: January 19, 2024
Jan 19, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued marketing denial orders (MDOs) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products and to Fontem US, LLC for blu PLUS+ brand e-cigarette products. The companies must not market or distribute these products in the United States or they risk FDA enforcement action … (leggi tutto)
FDA Accepts PMA Application Seeking Approval of TTFields Therapy in NSCLC for Filing
Jan 18, 2024 – A premarket approval (PMA) application regarding the addition of tumor-treating fields (TTFields) to standard-of-care (SOC) therapies in patients with non–small cell lung cancer (NSCLC) after disease progression on or following platinum-based treatment has been accepted for filing by the FDA. The PMA was supported by data from the phase 3 LUNAR study (NCT02973789) in which TTFields therapy paired with standard … (leggi tutto)
FDA Grants Fast Track Status to NX-5948 for Relapsed/Refractory CLL/SLL
Jan 17, 2024 – The FDA has granted fast track designation to the novel BTK degrader NX-5948 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two lines of therapy, including a BTK inhibitor and a BCL2 inhibitor. The investigational, orally administered, small molecule degrader was designed to bind to BTK and the cereblon … (leggi tutto)
FDA Roundup: January 16, 2024
Jan 16, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced an open period for applications to support the development, implementation, and evaluation of a human abuse potential (HAP) study on the use of botanical kratom. Addressing the use of botanical Kratom is a priority as the FDA works to characterize its abuse potential … (leggi tutto)
Dall’ASCO
CheckMate-722: No Survival Benefit With Nivolumab Plus Chemotherapy in EGFR-Mutated Metastatic NSCLC
Jan 23, 2024 – EGFR tyrosine kinase inhibitors (TKIs) are used to treat EGFR-mutated metastatic non–small cell lung cancer (NSCLC), but most patients develop a resistance to these treatments. Since immunotherapy plus chemotherapy is one of the standard treatment options in advanced lung cancer, the phase 3 CheckMate-722 trial set out to determine if immunotherapy would still have the same benefit after EGFR TKI failure … (leggi tutto)
Prostate Cancer Foundation Recommends PSA Screening as Early as Age 40 for Black Men
Jan 22, 2024 – Black men are more likely to develop prostate cancer, present with prostate cancer at younger ages, and die of the disease than White men. The Prostate Cancer Foundation convened a panel to develop prostate cancer screening guidance specifically for Black men, based on the available evidence and expert opinion. The panel recommended that Black men consult with their medical … (leggi tutto)
Prostate Cancer Incidence Is Rising Globally, With Higher Mortality in Lower-Income Countries
Jan 22, 2024 – Between 1990 and 2019, prostate cancer incidence increased globally. Countries in higher-income World Bank regions experienced the highest cancer incidence but also the highest decrease in mortality rates. Countries in low-income World Bank regions experienced the lowest incidence but highest mortality rates. Screening and therapeutic strategies may explain the disparities in outcomes between World Bank regions. … (leggi tutto)
Studies Confirm the Utility of ctDNA in Guiding Adjuvant Chemotherapy in CRC
Jan 20, 2024 – ctDNA is an established marker of minimal residual disease (MRD) in colorectal cancer (CRC), but its clinical application in guiding treatment decisions is in its infancy. Two trials, BESPOKE CRC and AGITG DYNAMIC-Rectal, confirm the utility of ctDNA in guiding adjuvant chemotherapy. BESPOKE CRC found that MRD was highly prognostic of recurrence. MRD was also predictive, with significant benefit from adjuvant chemotherapy observed … (leggi tutto)
CheckMate-8HW: First-Line Nivolumab Plus Ipilimumab Improves PFS Versus Chemotherapy in MSI-H/dMMR mCRC
Jan 20, 2024 – CheckMate-8HW represents the first phase 3 trial evaluating first-line nivolumab plus ipilimumab in patients with high-level microsatellite instability or deficient mismatch repair (MSI-H/dMMR) metastatic colorectal cancer (mCRC). At median follow-up, there was a 79% reduction in the risk of disease progression or death with the combination compared with standard therapy, with less toxicity … (leggi tutto)
GALAXY: ctDNA Negativity Linked to Improved DFS in Resectable Colorectal Cancer
Jan 20, 2024 – Longer-term follow-up data show that ctDNA continues to be a powerful prognostic biomarker and shows potential as a predictive biomarker. Analysis from the GALAXY trial shows that patients with colorectal cancer (CRC) with sustained circulating tumor DNA (ctDNA) clearance postadjuvant chemotherapy are less likely to experience recurrence compared with those who have transient or no ctDNA clearance … (leggi tutto)
People With Local Recurrence After Watch-and-Wait Approach Experience a Greater Risk of Distant Metastases Versus Total Mesorectal Excision in Rectal Cancer
Jan 20, 2024 – Local regrowth after a watch-and-wait approach is an independent risk factor for development of distant metastases in patients with rectal cancer after neoadjuvant therapy. Patients with local regrowth under a watch-and-wait approach have a higher risk of distant metastases development compared with those whose disease is managed by total mesorectal excision (TME). These findings support the need for close surveillance … (leggi tutto)
Tinengotinib Demonstrates Promising Efficacy, Safety in Previously Treated Cholangiocarcinoma
Jan 19, 2024 – Tinengotinib features a high binding affinity to FGFR2, which makes it an attractive agent for FGFR inhibitor (FGFRi)-refractory cholangiocarcinoma (CCA). In a phase 2 trial of tinengotinib, overall disease control rates were 94.7% in patients with FGFR2 fusion/rearrangements, 88.9% in patients with other FGFR alterations, and 75% in patients with FGFR wild type (FGFRwt) … (leggi tutto)
EMERALD-1 Trial Shows PFS Benefit With Addition of Durvalumab/Bevacizumab to TACE in Unresectable, Embolization-Eligible HCC
Jan 19, 2024 – For patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization, transarterial chemoembolization (TACE) has been the standard of care for the past 20 years. In the randomized, phase 3 EMERALD-1 trial, durvalumab/bevacizumab plus TACE provided a significant progression-free survival (PFS) benefit over placebo plus TACE. This represents the first trial to show improved outcomes with a systemic therapy added … (leggi tutto)
Thoracoscopic Esophagectomy Is Associated With Favorable Survival in Stage I-III Thoracic Esophageal Cancer
Jan 18, 2024 – The phase 3 MONET trial compared thoracoscopic esophagectomy to open transthoracic esophagectomy in patients with stage I-III thoracic esophageal cancer. Three-year overall survival (OS) was 82.0% and 70.9% in the thoracoscopic esophagectomy and open transthoracic esophagectomy groups, respectively. Patients in the thoracoscopic esophagectomy group had a greater 3-year …. (leggi tutto)
KEYNOTE-585 and MATTERHORN Shed Light on Perioperative Chemoimmunotherapy as a Potential Standard of Care for Resectable G/GEJ Cancer
Jan 18, 2024 – Recent efforts to improve outcomes for patients with resectable gastric and gastroesophageal junction (G/GEJ) cancer focus on adding immunotherapy to perioperative FLOT, a current standard of care. Data from the KEYNOTE-585 trial demonstrate a clear increase in pathologic complete responses (pCRs) with perioperative pembrolizumab plus FLOT versus FLOT alone but more modest improvements in survival … (leggi tutto)
ESCORT-NEO: pCR Data Favor Addition of Immunotherapy to Neoadjuvant Therapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Jan 18, 2024 – ESCORT-NEO is the first phase 3 trial to compare neoadjuvant chemoimmunotherapy with chemotherapy alone in resectable locally advanced esophageal squamous cell carcinoma (SCC). The addition of the PD-1 inhibitor camrelizumab to neoadjuvant chemotherapy significantly improved the pathologic complete response (pCR) rates, meeting one of the coprimary endpoints of the trial. Adding camrelizumab to chemotherapy did not increase the incidence of preoperative adverse events or surgical complications … (leggi tutto)
Implementing Policy- and System-Level Interventions to Address Rural Health Disparities in Patients With Cancer
Jan 18, 2024 – Disparities in cancer outcomes, including a heightened risk of adverse cancer outcomes, are prevalent among rural populations. Policy- and system-level interventions may help target areas where rural populations are disproportionately dealing with issues of insurance coverage and geographic disparities in care. Rural–urban disparities in cancer outcomes are a widely recognized health problem that has persisted over time …. (leggi tutto)
Resectable Mismatch Repair–Deficient Gastric Cancer: Is the Future Immunotherapy?
Jan 18, 2024 – Mismatch repair deficiency (MMRd)/microsatellite instability is a validated biomarker for immune checkpoint inhibition (ICI) across several tumor types, including gastric cancer. A pooled analysis of patients with operable MMRd gastric cancer revealed that chemotherapy does not add benefit to this subset of patients, yet chemotherapy is still considered a standard option for perioperative treatment. Early phase 2 data suggest that … (leggi tutto)
Selecting Patients for Immunotherapy Clinical Trials in Soft-Tissue Sarcomas: A Look Back at ASCO23
Jan 18, 2024 – Histology remains the most important predictive factor of response to immunotherapy in sarcoma, with alveolar soft-part sarcomas (ASPSs), angiosarcomas, and undifferentiated pleomorphic sarcomas (UPSs) being the most immune-sensitive sarcoma types, and presence of tertiary lymphoid structures being the most important predictive biomarker of response. New combinations with tyrosine kinase inhibitors (TKIs) … (leggi tutto)
ctDNA Testing Affects Well-Being, Reducing Anxiety in Patients With CRC
Jan 16, 2024 – The vast majority of patients (89%) said that they valued the additional information obtained from ctDNA testing, irrespective of the findings; 86% of patients said they would continue using ctDNA tests for monitoring purposes. The findings revealed no significant differences in the general anxiety and depression scores between patients who are ctDNA negative and ctDNA positive … (leggi tutto)
Pillole dall’AIFA
22 gennaio 2024 – Modifica Registro BRUKINSA (MZL)
Leggi tutto
22 gennaio 2024 – Riepilogo dei pagamenti a titolo di Ripiano della spesa farmaceutica acquisti diretti anno 2022 – Aggiornamento del 22/01/2024
Leggi tutto
22 gennaio 2024 – Titolari di incarichi politici, di amministrazione, di direzione o di governo – aggiornamento sezione
Leggi tutto
19 gennaio 2024 – Il Centro di Coordinamento Nazionale dei Comitati Etici (CCNCE) organizza tre incontri con i Comitati Etici Territoriali (CET)
Leggi tutto
19 gennaio 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
Leggi tutto
18 gennaio 2024 – Esiti della riunione della Commissione Tecnico Scientifica (CTS)
Leggi tutto
17 gennaio 2024 – EMA conferma la raccomandazione di non rinnovare l’autorizzazione all’immissione in commercio di Blenrep, un medicinale per il mieloma multiplo
Leggi tutto
17 gennaio 2024 – Sunset Clause – Warning di prossima decadenza del 15 gennaio 2024
Leggi tutto
Dedicato ai Soci
Opportunità di lavoro in Oncologia
Consulta le posizioni disponibili nella vetrina riservata ai Soci AIOM o scarica il modulo per richiedere la pubblicazione di annunci
Appuntamenti
NELL’AGENDA DISPONIBILE SUL SITO DELL’ASSOCIAZIONE TUTTE LE INFORMAZIONI SUGLI EVENTI AIOM NAZIONALI, REGIONALI e ALTRI APPUNTAMENTI PATROCINATI DA AIOM
