Comitato scientifico editoriale: Giuseppe Aprile, Consuelo Buttigliero, Paolo Carlini, Maria Vittoria Dieci, Massimo Di Maio, Raffaele Giusti, Sara Lonardi, Domenica Lorusso, Cristina Masini, Laura Noto, Silvia Novello, Filippo Pietrantonio, Giuseppe Procopio, Daniele Santini Editore: Intermedia – Direttore Responsabile: Mauro Boldrini
Oggi in Oncologia
Five-Year Overall Survival for Patients With Advanced NonSmall-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study
Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1) –expressing nonsmall-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS Eligible patients had confirmed locally advanced/metastatic NSCLC … (leggi tutto)
Un altro dato a lungo termine (follow-up mediano 60,6 mesi) che attesta l’efficacia degli immunocheckpoint inibitori nel trattamento del NSCLC in stadio avanzato viene pubblicato sul Journal of Clinical Oncology da E. B. Garon e coll. Lo studio evidenzia come pembrolizumab si associ ad una sopravvivenza a 5 anni pari al 23,2% per i pazienti naïve e al 15,5% per i pazienti pretrattati. Lo studio comprendeva 101 pazienti naïve e 449 pretrattati che avevano ricevuto pembrolizumab al dosaggio di 2 mg/kg ogni 3 settimane o 10 mg/kg ogni 2 o 3 settimane. A novembre 2018, l’82% dei pazienti erano deceduti (n = 450) e la sopravvivenza globale mediana risultava di 22,3 mesi per i pazienti treatment-naïve e 10,5 mesi per i pretrattati. Nei pazienti con un’espressione di PD-L1 ≥ 50%, la sopravvivenza a 5 anni è del 29,6% nei pazienti naïve e 25,0% nei pretrattati. Per quanto riguarda la tossicità, rispetto all’analisi condotta a 3 anni solo 3 nuovi eventi farmaco-correlati di grado 3 si sono verificati (ipertensione, intolleranza al glucosio e reazione di ipersensibilità). Nessun evento di grado 4 o 5 in questo lasso temporale. Il dato rafforza il risultato di efficacia sia nella prima linea che in linee successive del trattamento con solo immunocheckpoint inibitore.
A multicenter, prospective phase II trial of gemcitabine plus axitinib in patients with renal cell carcinoma with a predominant sarcomatoid component
We conducted a multicenter, phase 2 trial using gemcitabine plus axitinib (GX) in patients with recurrent or metastatic sarcomatoid renal cell carcinoma (SRCC) to evaluate its efficacy and safety. Methods Patients with advanced RCC and a sarcomatoid component of ≥25% on resected kidney or exclusive sarcomatoid carcinoma on needle biopsy were included. Patients received gemcitabine 1000 mg/m2 intravenously on needle biopsy were included. Patients … (leggi tutto)
Il carcinoma renale sarcomatoide è una entità abbastanza rara; nonostante questo, la prognosi dei pazienti che presentano tale istologia è assai infausta. Molto spesso i pazienti che presentano all’esame istologico una componente sarcomatoide superiore al 50% non possono accedere ai trials clinici. Benchè siano molte le limitazioni di questo studio, prima tra tutti la bassa numerosità campionaria per la rarità della patologia, in secondo luogo l’assenza di una centralizzazione per il calcolo della percentuale della componente sarcomatoide e la valutazione della risposta, i clinici ed i patologi che hanno partecipato a questo trial promettente erano esperti di patologia genito-urinaria. La combinazione di un trattamento chemioterapico come la gemcitabina ed axitinib ha dimostrato una incoraggiante efficacia in un setting di pazienti con una malattia molto eterogenea e aggressiva, dove la risposta ai classici TKI anti-VEGFR spesso fosse assai deludente. Anche l’immunoterapia combinata alla chemioterapia, concludono gli autori, potrebbe essere un approccio alternativo a quanto proposto in questo studio (sono già in corso studi di fase 1).
PARAGON: A Phase II study of anastrozole in patients with estrogen receptor-positive recurrent/metastatic low-grade ovarian cancers and serous borderline ovarian tumors
Treatment options are limited for patients with recurrent/metastatic low-grade ovarian cancers (LGOCs) and serous borderline ovarian tumors (SBOTs) as response rates to chemotherapy are low. A subset of patients appears to derive clinical benefit from antiestrogens, but most studies have been retrospective and clinical benefit rates (CBR) remain uncertain. The primary aim of PARAGON was to prospectively investigate the CBR of anastrozole, an aromatase inhibitor … (leggi tutto)
Lo studio riporta i dati di 36 pazienti con tumori sierosi di basso grado, che esprimevano recettori ormonali e che presentavano una recidiva di malattia, trattate con anastrozolo. Il farmaco si è rivelato molto efficace con un 61% di pazienti non progredite a 6 mesi dall’inizio del trattamento, 14% di risposte parziali, e una mediana di sopravvivenza libera da progressione di 11 mesi. Lo studio riporta l’attenzione all’importanza della ormonoterapia nei tumori ovarici e sierosi di basso grado in particolare.
In Europa
EU Panel Backs Expanded Indication of Ibrutinib Combos in CLL and Waldenstrom Macroglobulinemia
June 28, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indications of ibrutinib to include use in combination with obinutuzumab for adult patients with previously untreated chronic lymphocytic leukemia (CLL), and also in combination with rituximab for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). Both positive opinions by the CHMP will now … (leggi tutto)
Atezolizumab Combo Approaches EU Approval for Frontline TNBC
June 28, 2019 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC). The CHMP recommendation, which is for patients with a PD-L1 expression level ≥1%, is based on data from the phase III IMpassion130 … (leggi tutto)
One additional country to benefit from EU-US mutual recognition agreement for inspections
June 27, 2019 – On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites for human medicines conducted in the different … (leggi tutto)
Dall’FDA
FDA Approves Bevacizumab Biosimilar
June 28, 2019 – The FDA has approved PF-06439535 (bevacizumab-bvzr), a bevacizumab biosimilar for the treatment of patients with metastatic carcinoma of the colon or rectum; unresectable advanced, metastatic, or recurrent non–small cell lung cancer (NSCLC); advanced and/or metastatic renal cell cancer, and persistent recurrent or metastatic carcinoma of the cervix. “Biosimilars like bevacizumab-bvzr can help increase access to impactful therapies, driving market … (leggi tutto)
FDA Approves Frontline Daratumumab/Rd in Transplant-Ineligible Myeloma
June 27, 2019 – The FDA has approved the combination of daratumumab with lenalidomide and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). The approval, which was granted through the agency’s Real-Time Oncology Review pilot program, is based on findings from the phase III MAIA (MMY3008) trial, in which the daratumumab regimen led to a 44% reduction in the … (leggi tutto)
FDA Approves Newly Designed Syringe for Lanreotide in GEP-NETs
June 24, 2019 – The FDA has granted an approval to a prefilled syringe for lanreotide, which has been designed to enable healthcare providers to administer the injection easier, for the treatment of adults with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETS). The indications for the treatment remain the same as that of the previously approved prefilled syringe, according to an … (leggi tutto)
FDA Lifts Partial Clinical Hold on Venetoclax Myeloma Trial
June 24, 2019 – The FDA has lifted a partial clinical hold that was placed on the phase III CANOVA (M13-494; NCT03539744) trial, which is examining venetoclax in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma that harbors t(11;14), according to AbbVie, the company that co-develops the BCL-2 inhibitor with Roche. The lift on the partial hold is based on an agreement on revisions to the CANOVA study protocol, which … (leggi tutto)
FDA Grants Priority Review to Niraparib for Late-Stage Ovarian Cancer
June 24, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application for niraparib for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 or more prior chemotherapy regimens, and who have either a BRCA mutation or have homologous recombination deficiency (HRD) and progressed >6 months after their last platinum-based chemotherapy. The designation is based on … (leggi tutto)
Dall’ASCO
ASCO Commends the National Academies of Sciences, Engineering, and Medicine for its Report on Guiding Cancer Control
June 28, 2019 – “We applaud the National Academies of Sciences, Engineering, and Medicine for its recommendations on cancer control in the United States. The report examines the oncology community’s efforts over the past 10 years and lays out a comprehensive path for addressing the complex issues facing the entire cancer care continuum, from government agencies to the individual physician. “As the report notes, stakeholders in the cancer community must work together to … (leggi tutto)
IMWG Consensus Recommendations on Imaging in Monoclonal Plasma Disorders
June 28, 2019 – Just as newer drugs have significantly improved outcomes for patients with multiple myeloma in the past decade, newer imaging techniques are upgrading detection of the disease, leading to earlier treatment, but standards to help guide clinicians on the optimal use of advanced imaging have lagged behind. Jens Hillengass, MD, Chief of Myeloma at Roswell Park Comprehensive Cancer Center, led an International Myeloma Working Group (IMWG) effort to … (leggi tutto)
ASCO Launches Task Force to Address the Cancer Care Gap in Rural America
June 25, 2019 – Despite progress being made in cancer survivorship – there are currently nearly 17 million cancer survivors in the United States – not everyone is benefiting equally, especially those patients living in rural communities across America. According to “The State of Oncology Practice in America, 2018: Results of the ASCO Practice Census Survey” report, although about 19% of the population live in rural areas, just 7% of oncologists practice there, limiting patients’ … (leggi tutto)
Pillole dall’Aifa
28 giugno 2019 – Registro Sonidegib (Novartis) – Attivazione web e pubblicazione schede di monitoraggio
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