Cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) with endocrine therapy (ET) improves progression-free survival (PFS) and overall survival (OS) in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Although preclinical and clinical data demonstrate a benefit in changing ET and continuing a CDK4/6i at progression, no randomized prospective trials have evaluated this approach … (leggi tutto)

La combinazione dell’inibitore della chinasi 4/6 ciclino-dipendente (CDK4/6i) con terapia ormonale (OT) migliora la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) nelle pazienti affette da carcinoma mammario metastatico (MBC) esprimente recettori ormonali positivi (HR+) e negativi al recettore del fattore di crescita epidermico umano 2 (HER2–). Sebbene i dati preclinici e clinici dimostrino un beneficio nel cambiare OT e continuare un CDK4/6i alla progressione, nessuno studio prospettico randomizzato ha valutato questo approccio.
Nello studio Maintain, di fase II, in doppio cieco, controllato con placebo, in pazienti con MBC HR+/HER2–, il cui tumore è progredito durante OT e CDK4/6i, le pazienti hanno cambiato OT (fulvestrant o exemestane) dall’OT utilizzato pre-random e sono state assegnate in modo casuale 1:1 al CDK4/6i ribociclib rispetto al placebo. La PFS era l’endpoint primario, definito come tempo dalla randomizzazione alla progressione della malattia o alla morte.
Delle 119 partecipanti randomizzate, 103 (86,5%) hanno ricevuto in precedenza palbociclib e 14 ribociclib (11,7%). C’è stato un miglioramento statisticamente significativo della PFS per le pazienti assegnate in modo casuale ad OT commutato più ribociclib (mediana, 5,29 mesi; 95% CI, da 3,02 a 8,12 mesi) rispetto a OT commutato più placebo (mediana, 2,76 mesi; 95% CI, da 2,66 a 3,25 mesi) HR, 0,57 (IC 95%, da 0,39 a 0,85); p = 0.006. A 6 e 12 mesi, il tasso di PFS è stato rispettivamente del 41,2% e del 24,6% con ribociclib, rispetto al 23,9% e al 7,4% con placebo.
Pertanto, dai risultati dello studio Maintain, si è evidenziato un significativo beneficio in termini di PFS per le pazienti con MBC HR+/HER2– che hanno cambiato OT e hanno ricevuto ribociclib rispetto al placebo dopo CDK4/6i precedente e diverso ET.

Nivolumab and relatlimab activity in advanced melanoma with prior progression on anti-programmed death-1/programmed death ligand 1 (PD-(L)1)-containing regimens is under investigation. RELATIVITY-047 demonstrated significantly improved progression-free survival (PFS) for nivolumab and relatlimab over nivolumab in previously untreated advanced melanoma … (leggi tutto)

Nel melanoma avanzato in progressione dopo un precedente schema immunoterapico con un anti-PD(L)1 è in fase di studio l’attività di nivolumab combinata a relatlimab. Lo studio RELATIVITY-047 ha dimostrato una sopravvivenza libera da progressione (PFS) significativamente migliorata per nivolumab e relatlimab rispetto a nivolumab nel melanoma avanzato precedentemente non trattato.
Il recente studio di fase I/IIa, in aperto RELATIVITY-020, parte D, ha valutato l’efficacia e la sicurezza di nivolumab e relatlimab nel melanoma avanzato con progressione durante o entro 3 mesi da 1 (D1) o ≥ 1 (D2) linee con regimi contenenti un anti-PD(L)1. La sicurezza era un endpoint primario. Sono stati valutati il tasso di risposta obiettiva (end point coprimario) e la PFS mediante revisione centrale indipendente in cieco (BICR).
518 pazienti (D1 = 354; D2 = 164) hanno ricevuto nivolumab e relatlimab. Tra i pazienti valutabili, il tasso di risposta obiettiva del BICR è stato del 12,0% (95% CI, da 8,8 a 15,8) in D1 (n = 351) e del 9,2% (95% CI, da 5,2 a 14,7) in D2 (n = 163). Le risposte sembravano migliori tra i pazienti con tumori che esprimevano il PDL 1 o LAG 3; tuttavia, alcune risposte sono state osservate anche in assenza di tale espressione (1%). La durata mediana della risposta non è stata raggiunta (95% CI, da 12,9 a non raggiunto) in D1 e 12,8 mesi (95% CI, da 6,9 a 12,9) in D2. La PFS mediana secondo il BICR era di 2,1 mesi (95% CI, da 1,9 a 3,5) in D1 e 3,2 mesi (95% CI, da 1,9 a 3,6) in D2; il tasso di PFS a 6 mesi è stato rispettivamente del 29,1% (95% CI, da 24,2 a 34,1) e del 27,7% (95% CI, da 20,5 a 35,4). L’incidenza di eventi avversi correlati al trattamento di grado 3-4 è stata del 15,0% in D1 e del 12,8% in D2. È stato riportato un solo caso di miocardite di grado 3 e nessun decesso correlato al trattamento.
Lo studio ha evidenziato che la combinazione di Nivolumab e relatlimab aveva un profilo di sicurezza gestibile, con anche un’attività clinica duratura in una percentuale di pazienti con melanoma avanzato pretrattato con regimi contenenti anti-PD-(L)1.

The increasing age-related cancer incidence being a major challenge in healthcare, the best approach for the management of cancer in the elderly relies on the structured cooperation among clinical oncologists, geriatricians, and other specialists. The diffusion of this special approach is, however, quite limited in high-income countries and is almost absent in those with lower incomes … (leggi tutto)

L’aumento dell’incidenza di cancro con l’aumentare dell’età rappresenta senza dubbio una sfida per qualunque servizio sanitario. Ed è ampiamente riconosciuto come l’approccio migliore per la gestione del cancro nell’anziano si basi sulla cooperazione strutturata tra oncologi clinici, geriatri e altri specialisti. Tuttavia, la diffusione di tale approccio multidisciplinare è limitata nei paesi ad alto reddito ed è quasi assente in quelli a basso reddito. Questo commento si propone di far luce sulle complesse ragioni della mancanza di diffusione di programmi dedicati alla gestione dell’oncologia negli anziani. La descrizione dei molti fattori da considerare nell’affrontare l’attuazione di tali programmi potrebbe essere utile per suggerire possibili soluzioni.

In Europa

Adding Atezolizumab to Cabozantinib Fails to Improve Clinical Outcomes and Increases Toxicity in Patients with RCC and Disease Progression on or After Previous ICI Treatment

Jun 13, 2023 – The CONTACT-03 is the first randomised, phase III study conducted in patients with cancer to examine the safety and efficacy of rechallenge with a PD-L1 inhibitor following progression on previous PD-(L)1 therapy. The results show an absence of clinical benefit and increased toxicity with continuation of PD-L1 inhibitor use in patients receiving tyrosine kinase inhibitor (TKI) therapy for immune checkpoint inhibitor (ICI)-resistant renal cell carcinoma (RCC) … (leggi tutto)

Clinical Benefit and Safety of Encorafenib Plus Binimetinib in Treatment-Naïve and Previously Treated Patients with BRAFV600-mutated Metastatic NSCLC

Jun 12, 2023 – A phase II PHAROS study represents the first clinical trial of encorafenib plus binimetinib in patients with BRAFV600E-mutated metastatic non-small cell lung cancer (NSCLC); the combination treatment showed substantial antitumour activity in this population. The protocol-defined primary endpoint was met, with an objective response rate (ORR) of 75% in treatment-naïve and 46% in previously treated patients. Objective responses were durable … (leggi tutto)

EMA Management Board: highlights of June 2023 meeting

Jun 09, 2023 – The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the EU regulatory framework fit for innovative medicines, support greater access to medicines for patients and better address major public health challenges of the future. The Board was updated on EMA’s response to COVID-19. Following the end of the public health emergencies of international concern ... (leggi tutto)

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 – 8 June 2023

Jun 09, 2023 – At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. The Committee did not start or conclude any referral procedures. … (leggi tutto)

EMA Recommends Extension of Indications for Nivolumab

Jun 09, 2023 – On 25 May 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product nivolumab (Opdivo). The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG. The CHMP adopted a new indication as follows: ... (leggi tutto)

Zanidatamab Demonstrates Meaningful Clinical Benefit with a Manageable Safety Profile in Patients with Treatment-Refractory, HER2-positive Biliary Tract Cancer

Jun 07, 2023 – In a global, multicentre, single-arm, phase IIb HERIZON-BTC-01 study, zanidatamab showed meaningful activity, including rapid and durable responses, with a favourable safety profile in the treatment of patients with HER2-positive biliary tract cancer with disease progression on previous gemcitabine-based therapy. It is the largest clinical study reported to date for HER2-amplified biliary tract cancer … (leggi tutto)

 


Talazoparib Plus Enzalutamide Improves rPFS Over Placebo Plus Enzalutamide in First-Line Treatment for Patients with mCRPC

Jun 07, 2023 – The results from the primary analysis of the all-comers population in the phase III TALAPRO-2 study support the consideration of the novel combination of talazoparib plus enzalutamide versus a standard of care, enzalutamide, as a first-line treatment option in patients with metastatic castration-resistant prostate cancer (mCRPC). Talazoparib plus enzalutamide resulted in clinically meaningful and statistically significant improvement in radiographic ... (leggi tutto)

Dall’FDA

FDA Grants Priority Review to Capivasertib Plus Fulvestrant in Advanced HR+ Breast Cancer

Jun 12, 2023 – The FDA has accepted and granted priority review designation to the new drug application for the combination of capivasertib and fulvestrant (Faslodex) for the treatment of patients with hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after endocrine-based therapy … (leggi tutto)

FDA Roundup: June 9, 2023

Jun 09, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. The FDA issued this letter to help ensure that health care providers and facilities are aware of a recall notice by Getinge/Maquet for Quadrox Oxygenators and have information about alternative devices … (leggi tutto)

FDA Approval Sought for Pembrolizumab Plus Chemotherapy in Biliary Tract Cancer

Jun 08, 2023 – The FDA has accepted for review a supplemental biologics license application (sBLA) seeking the approval of pembrolizumab (Keytruda) plus standard chemotherapy comprised of gemcitabine and cisplatin for use in patients with locally advanced unresectable or metastatic biliary tract cancer. The application was supported by data from the phase 3 KEYNOTE-966 trial (NCT04003636), in which the addition of the immunotherapy … (leggi tutto)

FDA Extends Review Period for Nirogacestat NDA in Desmoid Tumors

Jun 08, 2023 – The FDA has extended the Prescription Drug User Fee Act decision date by 3 months to allow more time to complete their review of the new drug application (NDA) seeking the approval of nirogacestat in the treatment of adult patients with desmoid tumors. The regulatory agency granted priority review to the NDA in February 2023 and had set an action date of August 27, 2023 … (leggi tutto)

FDA Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Multiple Myeloma

Jun 07, 2023 – A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel (cilta-cel; Carvykti) for use in adult patients with relapsed and lenalidomide (Revlimid)-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), has been submitted to the FDA … (leggi tutto)

Dall’ASCO

Jennifer A. Woyach, MD, on New Findings on CLL, COVID-19, and Treatment With Obinutuzumab Plus Venetoclax

Jun, 2023 – Jennifer A. Woyach, MD, of The Ohio State University Comprehensive Cancer Center, discusses results of a phase III study showing that progression-free survival with ibrutinib plus obinutuzumab plus venetoclax is not superior to ibrutinib plus obinutuzumab for treatment-naive older patients with chronic lymphocytic leukemia (CLL) in the setting of the COVID-19 pandemic … (leggi tutto)

ASCO-CAP Guideline Update Confirms Previous Recommendations for HER2 Testing in Breast Cancer

Jun 08, 2023 – There is currently no justification for a new designation of HER2 test results for patients with immunohistochemistry (IHC) findings that indicate low levels of HER2, such as an IHC score of 0 or 1+. It is not clear whether IHC testing is sensitive enough to consistently detect the lowest levels of the HER2 protein (ie, whether IHC 0 truly means no HER2 is present) … (leggi tutto)

Comprehensive Genomic Profiling: A Required Tool for Precision Oncology

Jun 06, 2023 – Access to comprehensive genomic profiling (CGP) and CGP-directed therapies is critical for patients with non–small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). In a study of NSCLC, negative single-gene testing completed before CGP doubled subsequent CGP test cancelations and increased CGP DNA extraction failures. In a retrospective study of mCRC, nearly half of patients with mCRC screened with CGP … (leggi tutto)

Real-World Brexucabtagene Autoleucel Data in Mantle Cell Lymphoma Consistent With ZUMA-2 Trial

Jun 06, 2023 – Real-world data of brexucabtagene autoleucel in patients with relapsed/refractory mantle cell lymphoma showed similar effectiveness and safety compared to findings from ZUMA-2. Multivariate analysis of the subgroups indicated that efficacy outcomes were consistent across different types of prior treatment (BTKi, bendamustine, or autologous stem cell transplant) and that patients treated with brexu-cel earlier (1-2 lines of therapy vs ≥ 3) … (leggi tutto)

Positive Responses Seen in Follicular Lymphoma When Epcoritamab Is Added to Rituximab and Lenalidomide

Jun 06, 2023 – Epcoritamab is a novel bispecific antibody that targets CD3 and CD20 and induces T-cell–mediated cytotoxic activity against CD20-positive malignant B cells. After a median follow-up of 11.4 months, of 104 patients where the efficacy was evaluable in the pooled analysis of the ongoing dose-escalation phase 1/2 EPCORE NHL-2, 98% had an overall response, and 87% had a CMR … (leggi tutto)

Pillole dall’AIFA

09 giugno 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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09 giugno 2023 – Comunicazione alle Regioni/Province autonome di Trento e Bolzano sull’entrata in vigore del DM istitutivo dei CET
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08 giugno 2023 – Nota informativa importante su antibiotici fluorochinolonici ad uso sistemico ed inalatorio
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07 giugno 2023 – Indicazioni operative per il censimento dei CET/CEN in OsSC e gestione del passaggio di competenze dai CEC
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