Salvage Ipilimumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma After Prior Immune Checkpoint Inhibitors 

Immune checkpoint inhibitors (ICIs) are standard therapy in metastatic renal cell carcinoma (RCC). The safety and activity of the combination of ipilimumab and nivolumab in patients who have received prior ICI targeting the programmed death 1 (PD-1) pathway remains unknown. We evaluated ipilimumab and nivolumab in patients with metastatic RCC after prior treatment with anti–PD-1 pathway- … (leggi tutto)

L’immunoterapia rappresenta oggi un’opzione di trattamento nel tumore renale; dall’approvazione di nivolumab come terapia di seconda o terza linea, numerosi sono stati gli studi che hanno testato gli Immuno Checkpoint Inibitori (ICI), da soli o in combinazione con tirosin-chinasi inibitori (TKI) o con altri ICI. 
Da qualche anno è nota la possibilità di proseguire il trattamento con il medesimo ICI “beyond progression”; sono invece ancora pochi i dati in merito alla possibilità di trattare i pazienti con altri ICI a fallimento di una precedente immunoterapia.
Lo studio di Anita Gul et al (già portato come poster all’ASCO 2019, con una casistica più ridotta, e recentemente pubblicato sul Journal of Clinical Oncology), ha testato la combinazione di ipilimumab e nivolumab in 45 pazienti con carcinoma renale (RCC) metastatico dopo un precedente trattamento con un ICI (il 76% era stato trattato con un anti-PD-1, il 24% con un anti-PD-L1). L’età mediana era di 62 anni (intervallo 21-82 anni). Ad un follow-up mediano di 12 mesi, la proporzione di risposte obiettive ad ipilimumab e nivolumab era del 20%. La sopravvivenza libera da progressione mediana è stata di 4 mesi (intervallo 0,8-19 mesi). Gli eventi avversi immuno-correlati (irAE) di qualsiasi grado con ipilimumab e nivolumab sono stati registrati in 29 (64%) dei 45 pazienti; gli irAE di grado 3 sono stati registrati in 6 (13%) dei 45 pazienti. 
La combinazione di ipilimumab e nivolumab ha dimostrato attività antitumorale con accettabile profilo di tossicità in pazienti con carcinoma renale metastatico che hanno ricevuto un precedente trattamento con ICI.

Olaparib for Metastatic Castration-Resistant Prostate Cancer

Multiple loss-of-function alterations in genes that are involved in DNA repair, including homologous recombination repair, are associated with response to poly(adenosine diphosphate–ribose) polymerase (PARP) inhibition in patients with prostate and other cancers. We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant ... (leggi tutto)

Lo studio di fase 3 randomizzato PROfound ha confrontato l’efficacia di olaparib rispetto alle nuove terapie ormonali (enzalutamide o abiraterone, a scelta del clinico) in pazienti con carcinoma della prostata metastatico resistente alla castrazione, in progressione durante terapia con abiraterone o enzalutamide. Lo studio includeva sia pazienti che avevano già ricevuto chemioterapia, sia pazienti non chemio-trattati. Tutti i pazienti mostravano alterazioni in almeno uno dei quindici geni, precedentemente individuati, noti per avere un ruolo diretto o indiretto nel homologous recombination repair: BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, e RAD54L. I pazienti della Coorte A (n = 245) avevano almeno una alterazione a carico di BRCA1, BRCA2 o ATM. I pazienti della Coorte B (n = 142) mostravano un’alterazione in almeno uno degli altri dodici geni. I pazienti erano randomizzati (2:1) a ricevere olaparib (300 mg BID) o, a scelta del clinico, enzalutamide (160 mg/die) o abiraterone (1000 mg/die più prednisone 5 mg BID), come gruppo di controllo. L’endpoint primario era la sopravvivenza libera da progressione (PFS) radiologica.
Nella Coorte A, la PFS radiologica è stata significativamente maggiore nel gruppo di pazienti trattati con olaparib, rispetto al gruppo di controllo (mediana di 7,4 vs 3,6 mesi; hazard ratio 0,34; IC 95%: 0,25-0,47; p < 0,001). La sopravvivenza globale mediana è stata di 18,5 mesi nel gruppo di pazienti che avevano ricevuto olaparib, contro i 15,1 mesi dei pazienti del gruppo di controllo, senza però raggiungere la significatività statistica (p = 0,02). Tuttavia è importante notare che l’81% dei pazienti del gruppo di controllo che ha avuto una progressione di malattia ha, a quel punto, ricevuto olaparib. Inoltre è stato riportato un beneficio significativo sulla PFS radiologica, derivante dall’assunzione di olaparib, anche nella popolazione generale (sia nella Coorte A sia nella Coorte B).
Pertanto, in pazienti con tumore della prostata metastatico resistente alla castrazione e con mutazioni dei geni BRCA1, BRCA2 o ATM, il trattamento con olaparib è associato ad una PFS più lunga rispetto ad un secondo trattamento con abiraterone o enzalutamide. Gli eventi avversi più frequenti sono stati la nausea e l’anemia, come già noto per questo farmaco.
 

In Europa  

EMA Accepts Application for Zanubrutinib in Waldenström Macroglobulinemia

Jun 19, 2020 – The European Medicines Agency (EMA) has validated and accepted a marketing authorization application for zanubrutinib for the treatment of patients with Waldenström macroglobulinemia who have received at least 1 prior therapy or as frontline treatment for patients who are ineligible for chemoimmunotherapy, according to BeiGene, Ltd, the manufacturer of the BTK inhibitor … (leggi tutto)

International regulators stress value of safe and effective vaccines

Jun 18, 2020 – EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). International regulators from around the world have come together and jointly developed these statements for healthcare professionals and the general public to give assurance that the regulatory processes for the … (leggi tutto)

NICE Rejects Caplacizumab-yhdp for Acute Episodes of Acquired TTP

Jun 17, 2020 – The United Kingdom’s National Institute for Health and Care Excellence (NICE) has chosen not to recommend caplacizumab-yhdp for use with plasma exchange and immunosuppression in the treatment of acute episodes of acquired thrombotic thrombocytopenic purpura (TTP) in adults and those aged 12 years and over who weigh at least 40 kg. The agency agreed that trial evidence … (leggi tutto)

NICE Recommends Entrectinib for ROS1+ Advanced NSCLC

Jun 16, 2020 – The United Kingdom’s National Institute for Health and Care Excellence (NICE) has recommended entrectinib as a treatment option for ROS1-positive advanced non­small cell lung cancer (NSCLC) in adults who have not received prior treatment with ROS1 inhibitors. The committee concluded that entrectinib can be considered cost effective,” NICE stated in its final appraisal document … (leggi tutto)

ESMO Academy 2020 Virtual Meeting

Jun 16, 2020 – In the framework of a thorough review of our activities in light of the non-completely resolved Coronavirus pandemic, the ESMO Academy 2020 will be held as a virtual meeting. At ESMO we believe it is vital not to stop research and education, and this decision reflects our commitment to continuously support the oncology community. The Virtual Academy will be held on 21-22 August … (leggi tutto)

Withdrawal of Application for the EU Marketing Authorisation of Erlotinib Accord

Jun 15, 2020 – On 28 May 2020, the European Medicines Agency (EMA) has informed that the Accord Healthcare S.L.U. withdrew its application for a marketing authorisation of Erlotinib Accord (erlotinib) for the treatment of non-small-cell lung cancer (NSCLC) and pancreatic cancer. The company withdrew the application on 11 May 2020. Erlotinib Accord was developed as a medicine for advanced or … (leggi tutto)

Annual report 2019 published

Jun 15, 2020 – EMA released its annual report that showcases the Agency’s efforts to protect and promote human and animal health in Europe and highlights the most significant achievements in 2019. For the first time, EMA’s annual report is available in a digital version. The reader can navigate through the digital content and explore certain topics in more depth, for example through interviews and … (leggi tutto)

Dall’FDA
 

FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma

Jun 18, 2020 – On June 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat, an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, as well as for adult patients with relapsed or refractory … (leggi tutto)

FDA Grants Fruquintinib Fast Track Status for mCRC

Jun 18, 2020 – The FDA has granted a fast track designation to fruquintinib for the treatment of patients with metastatic colorectal cancer (mCRC) who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, VEGF-directed therapy, and if RAS wild-type, EGFR-directed therapy, according to a recent announcement by Chi-Med. Chi-Med retains all rights to fruquintinib outside of … (leggi tutto)

Rolling Submission Completed for Umbralisib in Previously Treated MZL and Follicular Lymphoma

Jun 17, 2020 – A new drug application (NDA) has been completed and submitted to the FDA for the accelerated approval of umbralisib (TGR-1202) as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma. “The completion of this NDA submission marks an important milestone in bringing us one step closer to providing umbralisib as a potential treatment … (leggi tutto)

Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

Jun 17, 2020 – The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection … (leggi tutto)

FDA Grants Liposomal Irinotecan Fast Track Status for Frontline Metastatic Pancreatic Cancer

Jun 17, 2020 – The FDA has granted a fast track designation to liposomal irinotecan for use in combination with 5-fluorouracil (5-FU)/leucovorin and oxaliplatin as a treatment for patients with previously untreated, unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). Data with the regimen, which is known as NALIRIFOX, is slated to be virtually presented as part of a final … (leggi tutto)

FDA Approves Pembrolizumab for TMB-High Tumors

Jun 16, 2020 – The FDA has approved pembrolizumab to treat adult and pediatric patients with unresectable or metastatic solid tumors that are tissue tumor mutational burden–high (≥ 10 mutations/megabase) and have progressed following prior therapy and who have no satisfactory alternative treatment options. The approval is based in part on the phase 2 KEYNOTE-158 trial, in which a link was established between … (leggi tutto)

FDA Approves Gemtuzumab Ozogamicin for CD33+ Pediatric AML

Jun 16, 2020 – The FDA has extended the indication of gemtuzumab ozogamicin for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. The decision was supported by data from the multicenter, randomized AAML0531 trial of 1,063 patients with newly diagnosed AML who were between the ages of 0 and 29 years. In the trial, patients were … (leggi tutto)

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use

Jun 15, 2020 – Today, the U.S. Food and Drug Administration is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease. Based on a recently completed non-clinical laboratory study, the FDA is revising the … (leggi tutto)

FDA Approves Lurbinectedin for Metastatic Small Cell Lung Cancer

Jun 15, 2020 – The FDA has approved lurbinectedin for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy, according to PharmaMar and Jazz Pharmaceuticals plc. The agent was approved under the FDA’s “Accelerated Approval” Program, which allows for the conditional approval of a therapy that fills an unmet need for a … (leggi tutto)

FDA Expands Gardasil 9 Indication for Prevention of Select HPV-Related Head and Neck Cancers

Jun 15, 2020 – The FDA has approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, according to Merck, the developer of the HPV 9-valent recombinant vaccine. The indication for oropharyngeal and head and neck cancer was granted accelerated approval based on the … (leggi tutto)

Dall’ASCO  

SIR 2020 Virtual: Holographic Visualization for Ablation of Liver Tumors

Jun 19, 2020 – Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools shows that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of the Society of Interventional Radiology (SIR) 2020 Annual Scientific Meeting (Abstract 297) … (leggi tutto)

Guidelines Recommend Widespread Genetic Testing for Metastatic Prostate Cancer, Associated Family History Risk

Jun 18, 2020 – The first multidisciplinary, consensus-driven framework for genetic testing in prostate cancer was borne out of the 2019 Philadelphia Prostate Cancer Consensus Conference, leading to the creation of comprehensive guidelines regarding the evaluation, management, and implementation therein. The guidelines strongly recommend germline and somatic testing for all men with metastatic … (leggi tutto)

American Cancer Society Updates Guideline for Diet and Physical Activity

Jun 17, 2020 – The American Cancer Society has updated its guideline on diet and physical activity for cancer prevention. Staying at a healthy weight, staying active throughout life, following a healthy eating pattern, and avoiding or limiting alcohol may greatly reduce a person’s lifetime risk of developing or dying from cancer. At least 18% of all cancer cases in the United States are related to a combination … (leggi tutto)

Dal mondo  


Oncology Centers Examine the Aftermath of COVID-19 on Clinical Trials

Jun 19, 2020 – From restrictions imposed by pharmaceutical sponsors to suspensions and slowed enrollment, the coronavirus disease 2019 (COVID-19) has affected clinical trial operation in oncology centers across the country. Institutions are slowly but steadily resuming their investigational efforts, examining both the temporary and lasting effects the pandemic has left on their centers. Declining accrual rates … (leggi tutto)

Pillole dall’Aifa  


18 giugno 2020 – Nuovo sistema gestione MEA finanziari – Ceritinib (Novartis) 

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18 giugno 2020 – Dichiarazioni ICMRA sull’importanza dei vaccini 

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17 giugno 2020 – COVID-19: Studio randomizzato italiano, nessun beneficio dal tocilizumab 

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16 giugno 2020 – Registri AIFA: informazioni sui dati dei trattamenti con i nuovi farmaci per la cura dell’epatite C 

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16 giugno 2020 – Medicinali contenenti oppioidi: nuove avvertenze da aggiungere sulle etichette 

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16 giugno 2020 – Nuovo sistema gestione MEA finanziari – Lenalidomide (Celgene) in associazione con Daratumumab (Janssen-Cilag) 

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