Oggi in Oncologia

Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial

In the primary analysis of CheckMate 9ER, nivolumab plus cabozantinib showed superior progression-free survival, overall survival, and objective response over sunitinib in patients with previously untreated advanced renal cell carcinoma (median follow-up of 18·1 months). Here, we report extended follow-up of overall survival and updated efficacy and safety. This open-label, randomised, phase 3 trial was done in 125 hospitals and cancer centres across 18 countries … (leggi tutto)

L’approvazione delle combinazioni di immunoterapia sta completamente stravolgendo il panorama terapeutico della prima linea del carcinoma renale metastatico permettendo un impatto sulla sopravvivenza e sulla qualità di vita dei nostri pazienti fino ad ora mai ottenuto.
L’update dei risultati dello studio CheckMate 9ER trial conferma l’efficacia rispetto al sunitinib della combinazione di nivolumab + cabozantinib in prima linea, ma tale combinazione non sembra incrementare l’overall survival (OS) nei pazienti a rischio favorevole secondo la classificazione dell’International Metastatic RCC Database Consortium (IMDC). Tali dati sono in linea con una recente metanalisi di Ciccarese et al. che mette in evidenza come le combinazioni di inibitori delle tirosin chinasi (TKI) ed immune checkpoint inhibitors (ICIs) sono in grado di incrementare l’overall response rate (ORR) e la progression free survival (PFS) ma non l’OS nel sottogruppo di pazienti a rischio favorevole.
Sebbene le attuali linee guida indichino la combinazione TKI + ICI come terapia standard anche nel sottogruppo di pazienti a prognosi favorevole, queste evidenze sembrano suggerire che la monoterapia con TKI possa rappresentare una valida alternativa terapeutica alle combinazioni di immunoterapia in pazienti selezionati a rischio favorevole, al fine di ridurre la tossicità clinica e finanziaria. I pazienti a rischio favorevole secondo la classificazione IMDC rappresentano infatti un gruppo eterogeneo, che comprende sia pazienti sintomatici, con malattia aggressiva e con metastasi in organi critici (fegato, encefalo), sia pazienti con malattia particolarmente indolente.
Considerando l’impatto delle combinazioni TKI + ICIs in termini di ORR e PFS, queste devono rappresentare il trattamento di scelta in caso di sintomi, elevato tumor burden o necessità di ottenere un rapido tumor shrinkage, mentre in caso di malattia asintomatica e a lenta crescita la monoterapia con TKI potrebbe rappresentare un’opzione plausibile.

Oncology clinical disruption during the COVID-19 pandemic: a COVID-19 and cancer outcome study

COVID-19 disproportionately impacted patients with cancer as a result of direct infection, and delays in diagnosis and therapy. Oncological clinical trials are resource-intensive endeavors that could be particularly susceptible to disruption by the pandemic, but few studies have evaluated the impact of the pandemic on clinical trial conduct. This prospective, multicenter study assesses the impact of the pandemic on therapeutic clinical trials at two large academic centers ... (leggi tutto)

È noto che la pandemia causata dal COVID-19 è stata in grado di impattare negativamente sull’outcome dei pazienti affetti da neoplasia a causa del ritardo direttamente dovuto all’infezione sia nella diagnosi sia nel trattamento.
In questo studio prospettico multicentrico, che ha coinvolto due istituzioni accademiche statunitensi e che ha arruolato 4756 pazienti, è stato valutato l’effetto della pandemia in termini di arruolamento in trials clinici dal dicembre 2019 al giugno 2021. Lo studio ha evidenziato un precoce decremento del numero di accruals (-46%), seguito da un progressivo recupero fino a livelli superiori al normale (+2.6%). Un trend simile è stato registrato anche per i nuovi studi attivati (-23.6%  +30.4%). I pazienti di razza non caucasica sono stati quelli che più frequentemente non hanno potuto beneficiare dell’arruolamento in trials clinici (adjusted odds ratio: 2.60; 95% CI 1.00-6.63).
La riduzione in termini di accrual è stata significativamente più evidente per gli studi accademici rispetto a quelli promossi dall’industria farmaceutica (p<0.05). Bisogna tuttavia sottolineare che gli studi sponsorizzati dall’industria hanno fatto registrare una minore qualità dei dati raccolti, con un più elevato numero di deviazioni dal protocollo di studio nel periodo pandemico rispetto allo standard (p<0.001).
Lo studio dimostra come la pandemia da COVID-19 non solo sia stata in grado di inficiare negativamente l’outcome dei pazienti oncologici a causa dell’effetto diretto dell’infezione ma abbia portato anche ad una significativa riduzione della possibilità per questi pazienti di accedere a terapie sperimentali. Il rapido recupero evidenziato in termini di accrual rappresenta tuttavia un dato confortante e dimostra quanto la comunità oncologica creda nella necessità di arruolare i pazienti negli studi sperimentali, al fine di favorire la ricerca di nuove efficaci opzioni terapeutiche e eventualmente incrementare la sostenibilità in oncologia.

In Europa


EMA Recommends Granting a Marketing Authorisation for Biosimilar Bevacizumab

Jul 05, 2022 – On 23 June 2022, the European Medicine 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 Vegzelma (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC), renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. … (leggi tutto)

A Subset of Patients with NSCLC Respond Poorly to the COVID-19 mRNA Vaccines

Jul 04, 2022 – A study of the vaccine-induced reactogenicity to COVID-19 mRNA vaccination in patients with non-small cell lung cancer (NSCLC) with emphasis on the antibody response to SARS-CoV-2 variants of concern including the Omicron variant revealed that although most patients with NSCLC generated a vaccine-specific antibody response comparable with the healthy volunteers, a subset of patients responded poorly to vaccination. Antibody titers in patients with NSCLC correlated with age … (leggi tutto)

FDA Grants Accelerated Approval to Dabrafenib in Combination with Trametinib for Unresectable or Metastatic Solid Tumours with BRAF V600E mutation

Jul 01, 2022 – On 22 June 2022, the US Food and Drug Administration (FDA) granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and paediatric patients ≥ 6 years of age with unresectable or metastatic solid tumours with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients … (leggi tutto)

Long-Term Benefit of Nivolumab Plus Low-Dose Ipilimumab in Previously Treated Patients with MSI-H/dMMR Metastatic Colorectal Cancer

Jun 30, 2022 – Nivolumab plus low-dose ipilimumab provided durable clinical benefit over 4 years of follow-up in the CheckMate 142 study, characterised by high response rates, low rates of disease progression, and long-term survival benefit. The safety profile was manageable, and no new safety signals were seen with longer follow-up. Findings from the longest duration of follow-up reported for combination of two immune checkpoint inhibitors (ICIs) in previously treated patients … (leggi tutto)

Long-Term Survival in a Significant Proportion of Patients with a 1p/19q Codeleted Anaplastic Oligodendroglioma

Jun 28, 2022 – EORTC 26951 and RTOG 9402 were two independent prospective randomised and practice-changing phase III studies. Prof. Martin J. van den Bent of the Department of Neurology, Erasmus MC Cancer Institute in Rotterdam, Netherlands and colleagues reported on 22 June 2022 in the Journal of Clinical Oncology very long-term mature and final survival analyses nearly 30 years after these studies were conceived. Both studies showed that the addition of procarbazine, lomustine.. (leggi tutto)

Dall’FDA

FDA Issues Warning for Increased Risk of Death, Serious AEs with Duvelisib in CLL/SLL

Jul 01, 2022 – The FDA has warned that treatment with duvelisib (Copiktra) has shown a possible increased risk of death and serious adverse effects (AEs) compared with ofatumumab (Arzerra) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The warning was based on 5-year survival results from the phase 3 DUO trial (NCT02004522) … (leggi tutto)

FDA Grants Orphan Drug Designation to Evorpacept for AML

Jul 01, 2022 – The FDA has granted an orphan drug designation to evorpacept (ALX148), a next-generation CD47 blocker, for use as a potential therapeutic option for patients with acute myeloid leukemia (AML), according to a news release from the drug developer, ALX Oncology. “Receiving orphan drug designation in AML, and previously in gastric cancer, from the FDA is an important regulatory milestone and reflects the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients  … (leggi tutto)

FDA Approval Sought for Subcutaneous Epcoritamab for Relapsed/Refractory LBCL

Jul 01, 2022 – Genmab A/S shared plans to submit a biologics license application to the FDA seeking the approval of subcutaneous epcoritamab for the treatment of patients with relapsed or refractory large B-cell lymphoma (LBCL) in the second half of 2022.The application is supported by findings from a LBCL cohort of the phase 2 EPCORE NHL-1 trial (NCT03625037), …. (leggi tutto)

FDA Grants Breakthrough Therapy Designation to Talquetamab for Relapsed/Refractory Myeloma

Jun 29, 2022 – he FDA has granted a breakthrough therapy designation to talquetamab for use as a potential therapeutic option in patients with relapsed or refractory multiple myeloma who received at least 4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody. The designation is supported by findings from the first-in-human, dose-escalation, phase 1/2 MonumenTAL-1 trial (NCT03399799; NCT04634552), in which the … (leggi tutto)

Liso-cel Approval Provides Earlier, Expanded Access to CAR T-cell Therapy in Second-line LBCL

Jun 29, 2022 – Second-line lisocabtagene maraleucel (liso-cel; Breyanzi) provides an earlier CAR T-cell treatment option that improves survival outcomes and produces a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma (LBCL), including those who are older and have comorbidities, according to Nilanjan Ghosh, MD, PhD. … (leggi tutto)

 

Dall’ASCO

Selecting Patients for PARP Inhibitors in the Treatment of Metastatic Castration-Resistant Prostate Cancer

Jun 30, 2022 – The treatment landscape for men with metastatic castration-resistant prostate cancer (mCRPC) and mutations in homologous recombination repair genes has expanded in recent years with FDA approvals and breakthrough designations for certain PARP inhibitors (PARPi). Although there is strong preclinical and clinical evidence for the use of PARPi for patients with BRCA1/2 (germline and/or somatic) mutations, perhaps even in the first-line mCRPC setting in combination with abiraterone acetate .… (leggi tutto)

Carboplatin for Patients With Triple-Negative Breast Cancer

Jun 30, 2022 – Neoadjuvant chemotherapy (NACT) is increasingly being used for patients with early triple-negative breast cancer (TNBC), and pathologic complete response (pCR) following NACT has been used as a surrogate marker for survival outcomes. Landmark clinical trials have shown an improvement in pCR with the addition of carboplatin to NACT, but this did not translate to improvement in long-term overall survival. Currently, the inclusion of carboplatin .… (leggi tutto)

FDA Proposed Ban on Menthol Cigarettes and Flavored Cigars Poised to Reduce Inequity of Cancer Outcomes

Jun 29, 2022 – A proposed new U.S. Food and Drug Administration (FDA) standard outlawing menthol cigarettes and flavored cigars could significantly reduce the incidence of cancer among minority groups and save thousands of lives in a population that disproportionately uses the addiction-enhancing flavored tobacco.According to the American Cancer Society, tobacco use remains the leading preventable cause of death in the United States, accounting for about 1 in 5 deaths each year. Additionally  … (leggi tutto)

The Impact of E-cigarettes on Cancer and Treatment: Questions and Controversies

Jun 29, 2022 – There is increasing evidence that e-cigarettes are associated with adverse outcomes in lung and cardiovascular health. Several preclinical studies highlight the adverse biologic effects of e-cigarette vapor, including oxidative stress and inflammatory response in lung epithelial cells. Given the limited timespan that e-cigarettes have been on the market, the longer-term safety of these products remains unknown. …. (leggi tutto)

Study Finds COVID-19 Vaccines Are Safe for Patients Treated With Immune Checkpoint Inhibitors for Lung Cancer

Jun 29, 2022 – Patients with cancer have received priority status to receive COVID-19 vaccinations, but limited data are available regarding the safety and efficacy of the vaccines for patients treated with immune checkpoint inhibitors for lung cancer. Now, a new study published by Hibino et al in the Journal of Thoracic Oncology has found that vaccines are safe and effective for these patients. Patients with cancer are at an increased risk for SARS–CoV-2 infection and severe COVID-19 ... (leggi tutto)

Pillole dall’AIFA

01 luglio 2022 – Aggiornamento elenco farmaci innovativi – Giugno 2022
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01 luglio 2022 – Ordine del giorno Riunione Commissione Tecnico Scientifica (CTS)
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01 luglio 2022 – Attivazione web e pubblicazione schede di monitoraggio – Registro DAURISMO (LMA)
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30 giugno 2022 – Liste sostanze attive – generici (aggiornamento)
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28 giugno 2022 – Al via il portale TrovaNormeFarmaco
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