Comitato scientifico editoriale: Giuseppe Aprile, Consuelo Buttigliero, Paolo Carlini, Massimo Di Maio, Domenica Lorusso, Laura Noto, Silvia Novello, Giuseppe Procopio, Daniele Santini Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study
Genomes of tumors that are deficient in DNA mismatch repair (dMMR) have high microsatellite instability (MSI-H) and harbor hundreds to thousands of somatic mutations that encode potential neoantigens. Such tumors are therefore likely to be immunogenic, triggering upregulation of immune checkpoint proteins. Pembrolizumab, an antiprogrammed death-1 monoclonal antibody, has antitumor activity against MSI-H/dMMR cancer. We report data from the phase II … (leggi tutto)
Il trial KEYNOTE-158, uno studio non randomizzato, in aperto, a coorti parallele, ha arruolato 233 pazienti con neoplasia avanzata non colorettale MSI-H (microsatellite instability-high), buon Performance Status secondo ECOG (0-1) e pretrattati con almeno una linea di terapia convenzionale. I pazienti – trattati con pembrolizumab alla dose flat di 200 mg ogni 21 gg – avevano 27 differenti tipi di neoplasie, tra le quali tumori dell’endometrio (21%), tumore gastrico (10%), adenocarcinoma pancreatici, delle vie biliari e del piccolo intestino (9% ognuno), carcinoma ovarico (6,5%) o neoplasia cerebrale primitiva (5,5%). I dati sono stati presentati dopo un follow-up mediano di 13 mesi. I risultati dello studio sono nel complesso favorevoli: è stato riportato un tasso di risposta del 34% e un 18% di stabilizzazione di malattia, con una sopravvivenza libera da progressione mediana di poco superiore ai 4 mesi e una sopravvivenza globale mediana di circa 2 anni. Inoltre, i pazienti avevano una probabilità di mantenere la risposta a 12 mesi dell’87% e a 24 mesi del 77%. Sebbene i dati confermino la sensibilità dei tumori con instabilità microsatellitare all’immunoterapia (dato che orienterebbe a una approvazione agnostica), si evidenzia che la probabilità di beneficio in termini di risposta non è paragonabile tra le differenti neoplasie: quasi il 60% nei tumori endometriali MSI-H, il 45% per neoplasie gastriche e colangiocarcinomi, il 20% nelle neoplasie pancreatiche e lo 0% nei tumori cerebrali primitivi con la stessa caratteristica molecolare.
Attending community-based lung cancer screening influences smoking behaviour in deprived populations
The impact of lung cancer screening on smoking is unclear, especially in deprived populations who are underrepresented in screening trials. The aim of this observational cohort study was to investigate whether a community-based lung cancer screening programme influenced smoking behaviour and smoking attitude in socio-economically deprived populations. Ever-smokers, age 55-74, registered at participating General Practices were invited to a community- … (leggi tutto)
Più della metà dei fumatori che hanno smesso di fumare dopo un controllo della salute polmonare in un programma di screening del tumore polmonare (lung cancer screening, LCS) di comunità adottato in un’area servita in modo insufficiente cita il programma come motivo alla base della cessazione del fumo.
A first version of the Pan-European Indoor Radon Map
A hypothetical Pan-European Indoor Radon Map has been developed using summary statistics estimated from 1.2 million indoor radon samples. In this study we have used the arithmetic mean (AM) over grid cells of 10 km × 10 km to predict a mean indoor radon concentration at ground-floor level of buildings in the grid cells where no or few data (N < 30) are available. Four interpolation techniques have been tested: inverse distance weighting (IDW), ordinary krig- ing … (leggi tutto)
Si tratta della prima mappa europea con dati anche riferiti all’Italia. Pur rimanendo il fumo di sigaretta il fattore di rischio principale per il tumore polmonare, il radon viene considerato un fattore di rischio importante, soprattutto nei casi di malattia in cui non vi sia stata abitudine tabagica. Avere dei dati europei e, nello specifico, italiani è certamente di aiuto nelle politiche decisionali e nelle valutazioni dell’esposizione. Dopo più di 10 anni di raccolta dati gli autori, con il supporto di 32 Paesi, sono ora in grado di fornire informazioni in questo contesto per il 50% del continente circa e, ovviamente, il loro lavoro di aggiornamento della mappa prosegue.
In Europa
Fostamatinib Slated for EU Approval in Chronic ITP
November 15, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate (fostamatinib) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who are refractory to other treatments. The recommendation is based on findings from the FIT Phase III clinical program, which included the … (leggi tutto)
EU Panel Backs Polatuzumab Vedotin Approval for DLBCL
November 15, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the antibody-drug conjugate (ADC) polatuzumab vedotin for use in combination with bendamustine and rituximab (BR) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for a hematopoietic stem cell transplant. The CHMP based its recommendation on … (leggi tutto)
Lenalidomide/Rituximab Combo Nears EU Approval for Follicular Lymphoma
November 15, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma. The positive opinion is primarily based on results from the phase III AUGMENT study, which showed that the combination reduced the risk of disease progression or death by 54% versus … (leggi tutto)
Adjuvant T-DM1 Approaches EU Approval for HER2+ Early Breast Cancer
November 15, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy. The CHMP based its recommendation on findings … (leggi tutto)
Dutch authorities hand over final building to EMA in Amsterdam
November 15, 2019 – Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanked the Dutch authorities for reaching this important milestone on time. EMA moved from London to Amsterdam in March 2019, and has since then been operating from temporary premises in Amsterdam Sloterdijk. Now that the Zuidas … (leggi tutto)
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
November 12, 2019 – Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee, Harald Enzmann … (leggi tutto)
‘Regulatory science to 2025’: live broadcast of post-consultation workshop
November 11, 2019 – The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ on 18-19 November. The draft strategy sets out working proposals on the key areas with which EMA intends to engage, in order to ensure that it has the regulatory tools to continue supporting the European medicines regulatory network and fulfil its ongoing mission in light of upcoming scientific. The … (leggi tutto)
Dall’FDA
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
November 15, 2019 – Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and … (leggi tutto)
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage
November 14, 2019 – Today, the U.S. Food and Drug Administration granted accelerated approval to zanubrutinib capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This is a life-threatening condition,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of … (leggi tutto)
FDA Grants Priority Review to Nivolumab/Ipilimumab in Advanced HCC
November 11, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma (HCC) who received prior therapy with sorafenib. The designation is based on results of a cohort from the phase I/II CheckMate-040 study (NCT01658878), in which nivolumab and ipilimumab were evaluated in this patient population at … (leggi tutto)
Dall’ASCO
Growing Field of Cardio-Oncology Boosted by Collaboration Between Leading Oncology and Cardiovascular Health Organizations
November 14, 2019 – Providing researchers with access to real-world cancer patient data has the potential to improve care and impact quality of life for cardio-oncology patients everywhere. To accomplish this, two science-based organizations, CancerLinQ LLC, a nonprofit subsidiary of the American Society of Clinical Oncology (ASCO), and the American Heart Association, the leading voluntary health organization devoted to a world of longer, healthier lives, are teaming up … (leggi tutto)
Pillole dall’Aifa
14 novembre 2019 – Attivazione web e pubblicazione schede di monitoraggio – Registro Lenvatinib (Eisai)
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