Anno XVIII – numero 751 – 7 gennaio 2020

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

Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer

Patients with metastatic colorectal cancer with the BRAF V600E mutation have a poor prognosis, with a median overall survival of 4 to 6 months after failure of initial therapy. Inhibition of BRAF alone has limited activity because of pathway reactivation through epidermal growth factor receptor signaling. In this open-label, phase 3 trial, we enrolled 665 patients with BRAF V600E–mutated metastatic colorectal cancer who had had disease progression after one or …(leggi tutto)

I pazienti affetti da tumore del colon retto metastatico con mutazione BRAF V600E hanno una prognosi severa, con una mediana di sopravvivenza globale tra i 4 e i 6 mesi dopo progressione dal trattamento di prima linea. BEACON è stato il primo studio di fase III a dimostrare un vantaggio in termini di sopravvivenza e di risposta obiettiva in questo setting di pazienti. Lo studio ha confrontato la combinazione di encorafenib (BRAF inibitore) e cetuximab (anti-EGFR) con o senza binimetinib (MEK inibitore) versus un trattamento standard a scelta dello sperimentatore con cetuximab in combinazione con irinotecano o FOLFIRI. Nell’analisi ad interim, con un follow-up di 7,8 mesi, la sopravvivenza globale mediana nei pazienti che hanno ricevuto la tripletta e risultata di 9,0 mesi versus 5,4 mesi nel gruppo di controllo (HR 0,52; IC 95%: 0,39-0,70; p < 0,001) con vantaggio significativo mantenuto in tutti i sottogruppi prepianificati. Il tasso di risposte obiettive e stato del 26% nel gruppo trattato con la tripletta versus 4% nel gruppo di controllo (p < 0,001). Lo studio non è stato formalmente potenziato per confrontare l’efficacia del trattamento con la tripletta rispetto alla doppietta, tuttavia, un comparabile beneficio rispetto al gruppo di controllo è stato registrato anche nel gruppo trattato con doppietta con una sopravvivenza globale mediana di 8,4 mesi (HR 0,60; IC 95%: 0,45-0,79; p < 0,001) ed un tasso di risposta significativamente maggiore (RR = 20%) rispetto al gruppo di controllo (p < 0,001). Eventi avversi di grado 3 o superiore si sono verificati nel 58% dei pazienti trattati con la tripletta, 50% con la doppietta e 61% trattati con controllo.

Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial

Denosumab is a fully human monoclonal antibody that binds to, and inhibits, the receptor activator of RANKL (TNFSF11) and might affect breast cancer biology, as shown by preclinical evidence. We aimed to assess whether denosumab combined with standard-of-care adjuvant or neoadjuvant systemic therapy and locoregional treatments would increase bone metastasis-free survival in women with breast cancer. In this international, double-blind, randomised … (leggi tutto)

D-CARE è uno studio di fase III con l’obiettivo di valutare l’efficacia del denosumab, in aggiunta alla terapia adiuvante o neoadiuvante standard del carcinoma mammario ad alto rischio (stadio II-III secondo AJCC v.7.0). Da giugno 2010 ad agosto 2012 sono state arruolate 4.509 donne in 389 centri distribuiti in 39 Paesi, randomizzate a ricevere: denosumab 120 mg s.c. ogni 3-4 settimane per i primi 6 mesi e poi ogni 12 settimane per i successivi 54 mesi, per un totale di 5 anni oppure placebo (stessa formulazione e stesso “timing”). Lo studio ha dimostrato che tale schedula intensiva di denosumab non ha apportato un beneficio clinico alle pazienti né in termini di sopravvivenza libera da metastasi ossee (end-point primario dello studio), nè di sopravvivenza libera da malattia (DFS). Inoltre, il 5% delle pazienti trattate con denosumab ha manifestato osteonecrosi della mandibola e la metà di queste non ha avuto risoluzione completa dell’evento. Il risultato negativo di questo trial è deludente sia perché riduce fortemente la validità dell’ipotesi che l’inibizione di RANKL possa avere un effetto antitumorale diretto, sia perché riduce l’impatto del risultato dello studio ABCSG18 che aveva dimostrato come una schedula meno intensiva di denosumab (60 mg s.c. ogni 6 mesi per 5 anni) potesse apportare un miglioramento della DFS in donne trattate in adiuvante con inibitori delle aromatasi.

Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial

Abiraterone acetate plus prednisone and enzalutamide are both used for the treatment of metastatic castration-resistant prostate cancer. We aimed to determine the best sequence in which to use both drugs, as well as their second-line efficacy. In this multicentre, randomised, open-label, phase 2, crossover trial done in six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant … (leggi tutto)

Abiraterone ed enzalutamide sono tra i farmaci più efficaci e meglio tollerati per il trattamento del carcinoma metastatico della prostata resistente alla castrazione (mCRPC), tuttavia non esistono studi prospettici che abbiano comparato head-to-head abiraterone ed enzalutamide, né valutato la miglior sequenza di trattamento. Questo è il primo studio di crossover, randomizzato, di fase 2, in aperto, che ha comparato due sequenze di trattamento per il mCRPC. Lo studio ha randomizzato (1:1) 202 pazienti con mCRPC, a ricevere abiraterone (1000 mg/die) più prednisone (5 mg 2 volte/die) seguito, dopo progressione del PSA, da enzalutamide (160 mg/die) (gruppo A; n= 101) o la sequenza opposta di trattamento (gruppo B; n=101). Gli obiettivi primari dello studio erano: il tempo alla seconda progressione del PSA (intervallo dall’inizio della terapia di prima linea alla progressione del PSA durante la seconda linea di terapia o morte per cancro della prostata) e la risposta del PSA in seconda linea di terapia. La progressione del PSA è stata definita come un incremento di 2 µg/L e del 25% dal nadir confermato da un successivo incremento dopo almeno 28 giorni. Per i pazienti senza riduzione dei valori di PSA, la progressione è stata definita come un incremento di 2 µg/L e del 25% rispetto al valore basale dopo 12 o più settimane di trattamento. La risposta del PSA è stata definita come una riduzione ≥ 30% rispetto al valore basale confermata da una successiva misurazione dopo almeno 28 giorni. Nello studio, il 74% dei pazienti nel gruppo A e il 75% dei pazienti nel gruppo B, ha effettuato il crossover alla seconda linea di terapia. Il tempo mediano alla seconda progressione del PSA è risultato migliore per la sequenza abiraterone seguito da enzalutamide rispetto alla sequenza opposta (19,3 vs 15,2 mesi, rispettivamente; hazard ratio [HR] 0,66; p = 0,036). La risposta del PSA in seconda linea di terapia è stata osservata nel 36% (26/73) dei pazienti trattati con enzalutamide e nel 4% (3/75) dei pazienti che hanno ricevuto abiraterone (P <.0001). Gli eventi avversi di grado 3 o 4 più comuni sono stati: ipertensione (27% dei pazienti nel gruppo A vs 18% nel gruppo B ) ed astenia (10% vs 4%, nei gruppi A e B, rispettivamente). In conclusione, questo studio suggerisce un beneficio nell’utilizzo di una sequenza di trattamento con inibitori del pathway del recettore degli androgeni, per il mCRPC: la sequenza abiraterone/prednisone seguito da enzalutamide migliora il tempo alla seconda progressione del PSA rispetto alla sequenza opposta e tale vantaggio sembrerebbe essere attribuito alla maggiore attività di enzalutamide in seconda linea, rispetto ad abiraterone (tempo mediano alla progressione del PSA in seconda linea nei pazienti che hanno effettuato il crossover: 3,5 vs 1,7 mesi).

Phase II Trial of Cediranib in Combination With Cisplatin and Pemetrexed in Chemotherapy-Naïve Patients With Unresectable Malignant Pleural Mesothelioma (SWOG S0905)

Antiangiogenic agents combined with chemotherapy have efficacy in the treatment of unresectable malignant pleural mesothelioma (MPM). Cediranib (AstraZeneca, Cheshire, United Kingdom), a vascular endothelial growth factor receptor and platelet-derived growth factor receptor inhibitor, demonstrated therapeutic potential in a prior phase I trial. We evaluated a phase II trial for efficacy. SWOG S0905 (ClinicalTrials.gov identifier: NCT01064648) randomly … (leggi tutto)

Il mesotelioma pleurico maligno è una patologia rara ma di grande rilevanza sociale. Ad oggi poche sono le opzioni terapeutiche disponibili e con scarsi risultati in termini di sopravvivenza. La ricerca di nuovi target terapeutici rappresenta pertanto una vera e propria sfida. Diverse evidenze hanno supportato la rilevanza del pathway angiogenico e dell’inibizione di VEGF e PDGF; ed è in questo contesto che si inserisce lo studio clinico SWOG S0905. Il trial ha randomizzato 92 pazienti con mesotelioma pleurico maligno (ogni istotipo) in fase avanzata di malattia (non resecabile) e chemio-naïve a cediranib o placebo in aggiunta a trattamento chemioterapico standard (platino e pemetrexed) per sei cicli seguito da cediranib o placebo a mantenimento. I risultati della sperimentazione hanno dimostrato un prolungamento della sopravvivenza libera da progressione (PFS) valutata con i criteri RECIST (7,2 mesi contro 5,6 mesi; hazard ratio (HR) 0,71; IC 80%: 0,54-0,95; p = 0,062) e un aumento significativo dei tassi di risposta valutati con i criteri RECIST modificati (50% vs 20%; p = 0,006). Non è stata osservata una differenza statisticamente significativa in sopravvivenza globale tra i due gruppi. La tripletta con cediranib è stata associata ad una scarsa compliance al trattamento rispetto al braccio con placebo e a tossicità gastrointestinale (diarrea G3-G4), disidratazione, perdita di peso ed ipertensione. In conclusione, a fronte del modesto beneficio in sopravvivenza osservato (1,4 mesi in PFS mediana e 1,5 mesi in sopravvivenza globale mediana rispetto alla sola chemioterapia) e del profilo di tossicità, gli stessi autori non ritengono opportuno proseguire lo sviluppo di cediranib in questo setting di malattia.

In Europa

EMA Management Board: highlights of December 2019 meeting

December 20, 2019 – The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new EMA building in Amsterdam Zuidas in January 2020. The move to the final building opens a new chapter for EMA and will allow the Agency to fully refocus on its mission of protecting public and animal health. However, Executive Director Guido Rasi stressed the … (leggi tutto)

Adjuvant T-DM1 Approved in Europe for HER2+ Early Breast Cancer

December 19, 2019 – The European Commission has approved ado-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 approval is based on findings from the phase III KATHERINE study, in which T-DM1 reduced the risk of invasive disease recurrence … (leggi tutto)

Launch of international pilot programme on inspection of manufacturers of sterile medicines

December 17, 2019 – EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme. This collaboration will allow EMA, EU national authorities (France and the United Kingdom … (leggi tutto)

4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system

December 17, 2019 – A report on the activities ensuring the safety of medicines carried out by EMA and the national competent authorities of the European Union (EU) Member States, Norway and Iceland from 2015 to 2018 shows that the EU pharmacovigilance system is strong and adaptable and has had a positive impact on public health. The report measures the longer-term impact of the pharmacovigilance legislation, which came into effect in July 2012, in terms of …(leggi tutto)

Dall’FDA

FDA Approves Olaparib for Frontline Maintenance in Pancreatic Cancer

December 30, 2019 – The FDA has approved the PARP inhibitor olaparib for the maintenance treatment of adult patients with germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The approval is based on data from the phase III POLO trial, which showed a progression-free survival (PFS) benefit with olaparib compared with placebo in this setting … (leggi tutto)

Pazdur Followed the Pathway of Greatest Resistance to the FDA

December 30, 2019 – Richard Pazdur, MD, a 2019 winner of the OncLive® Giants of Cancer Care® award for community outreach, education, and cancer policy, set out to be a leader in medicine and a teacher of doctors. He achieved that and more, turning the oncology drugs section of the FDA from a poorly understood and lead-footed division into a fast-moving and patient-responsive entity. Pazdur, now director of the FDA’s Oncology Center of Excellence (OCE) … (leggi tutto)

FDA Accepts Sacituzumab Govitecan Application for TNBC

December 27, 2019 – The FDA has accepted a biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease, according to a statement from the company developing the antibody-drug conjugate (ADC), Immunomedics. A prior application for sacituzumab govitecan received a complete response letter (CRL) from the FDA in … (leggi tutto)

FDA Approval Sought for Selinexor in DLBCL

December 23, 2019 – Karyopharm Therapeutics Inc., has submitted a new drug application (NDA) to the FDA for selinexor for the treatment of patients with relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) who have received at least 2 prior multiagent therapies and who are ineligible for stem cell transplantation, including CAR T-cell therapy. “Earlier this year we reported compelling results from the phase IIb SADAL study investigating selinexor in patients with … (leggi tutto)

FDA Grants ADP-A2M4 RMAT Designation for Synovial Sarcoma

December 23, 2019 – The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ADP-A2M4 (MAGE-A4) as a treatment for patients with synovial sarcoma. The RMAT designation was based on updated data from a phase I trial that was presented at the 2019 CTOS Annual Meeting, in which 50% of patients achieved clinical responses with ADP-A2M4. The agent is a genetically engineered autologous-specific peptide-enhanced …(leggi tutto)

FDA Grants SP-2577 Fast Track Status for Ewing Sarcoma

December 23, 2019 – The FDA has granted fast track designation to the potent reversible LSD1 inhibitor SP-2577 (seclidemstat) for the treatment of relapsed/refractory patients with Ewing sarcoma. Currently, the agent is being evaluated in an ongoing, open-label, nonrandomized phase I trial (NCT03600649) in patients with Ewing sarcoma. In the study, researchers are aiming to find an optimal dose of SP-2577 using an accelerated dose-escalation followed … (leggi tutto)

FDA Approval Sought for Tucatinib in HER2+ Breast Cancer

December 23, 2019 – Seattle Genetics, Inc., has submitted a new drug application (NDA) to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting. The NDA is … (leggi tutto)

FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

December 20, 2019 – The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting. The approval is based on findings from the phase II DESTINY-Breast01 trial, updated data of which were presented at the 2019 San Antonio Breast Cancer Symposium. In the …(leggi tutto)

FDA Approval Sought for Margetuximab in HER2+ Metastatic Breast Cancer

December 20, 2019 – MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The BLA is based on data from the phase III SOPHIA trial. Data from a prespecified second interim OS analysis presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) showed that at a median follow-up of 15.6 months, the …(leggi tutto)

FDA Approval Sought for Rituximab Biosimilar

December 20, 2019 – A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798, according to the developers, Amgen and Allergan. The application is based on analytical, pharmacokinetic, and clinical data, and also pharmacology and toxicology data from 2 clinical trials, results of which showed that there were no clinically meaningful differences between ABP 798 and reference rituximab. “The US filing for ABP 798 … (leggi tutto)

FDA Grants Priority Review to UGN-101 for Urothelial Cancer

December 19, 2019 – The FDA has granted a priority review designation to a new drug application (NDA) for UGN-101 (mitomycin gel) for the treatment of patients with low-grade, upper tract urothelial cancer (UTUC). The designation is based on results from the pivotal phase III OLYMPUS trial, in which a final analysis showed that UGN-101 elicited a complete response (CR) rate of 59% in this patient population. Under the Prescription Drug User Fee Act, the … (leggi tutto)

FDA Approval Sought for Tazemetostat in Follicular Lymphoma

December 19, 2019 – A new drug application (NDA) has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy. The submission, which is for an accelerated approval, is mostly based on updated results of an ongoing phase II trial, which showed that the first-in-class EZH2 inhibitor elicited an objective response … (leggi tutto)

FDA approves new type of therapy to treat advanced urothelial cancer

December 18, 2019 – Today, the U.S. Food and Drug Administration granted accelerated approval to Enfortumab vedotin-ejfv, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers. Padcev is indicated for the treatment of adult patients with locally advanced (when cancer has grown too large to be surgically … (leggi tutto)

FDA Approval Sought for Liso-Cel in Large B-Cell Lymphoma

December 18, 2019 – Bristol-Myers Squibb has submitted a biologics license application (BLA) to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The BLA is based on data from the multicenter phase I TRANSCEND NHL 001 study, in which treatment with liso-cel resulted in an objective … (leggi tutto)

FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC

December 18, 2019 – The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E–mutant metastatic colorectal cancer (mCRC) following up to 2 prior lines of therapy. The designation is based on findings from the phase III BEACON CRC study, which evaluated encorafenib plus cetuximab with or without binimetinib in … (leggi tutto)

FDA Panel Supports Tazemetostat for Epithelioid Sarcoma

December 18, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11-0) in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery. The purpose of the hearing was to discuss data supporting a new drug application (NDA) for an accelerated approval of tazemetostat in this setting, and to determine whether the overall response … (leggi tutto)

FDA Grants Tucatinib Breakthrough Designation for HER2+ Breast Cancer

December 18, 2019 – The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The designation, which will expedite the development and regulatory review of … (leggi tutto)

Statement on low-cost biosimilar and interchangeable protein products

December 17, 2019 – Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is key for expanding access to these products and increasing competition, ultimately helping American patients. In March 2020 most protein products that were approved as drug products (including every insulin currently on the market) will open up to biosimilar and interchangeable competition. However, “chemically …(leggi tutto)

FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

December 17, 2019 – The U.S. Food and Drug Administration today announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. – Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes. Following a rigorous science-based review of the premarket tobacco product applications (PMTAs) submitted by the … (leggi tutto)

FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

December 17, 2019 – The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes (MDS) who harbor IDH1 mutations. The designation is based on results from an MDS substudy of a phase I trial (NCT02074839) looking at ivosidenib in patients with advanced hematologic malignancies who have IDH1 mutations. In the MDS cohort, findings showed an overall … (leggi tutto)

FDA Panel Supports Pembrolizumab for High-Risk NMIBC

December 17, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 supporting the approval of a new drug application (NDA) for pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy. The NDA is based on findings from … (leggi tutto)

FDA Approval Sought for Belantamab Mafodotin in Relapsed/Refractory Myeloma

December 17, 2019 – A biologics license application (BLA) has been filed with the FDA for belantamab mafodotin (GSK2857916) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory drug (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody, according to GlaxoSmithKline (GSK), the manufacturer of the BCMA-targeting antibody-drug conjugate (ADC). The BLA is based on … (leggi tutto)

FDA Panel Backs Maintenance Olaparib for Metastatic Pancreatic Cancer

17, 2019 – The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy. The FDA scheduled an Oncologic Drugs Advisory Committee hearing to discuss a supplemental new drug … (leggi tutto)

FDA Approval Sought for Lurbinectedin in Small Cell Lung Cancer

December 17, 2019 – A new drug application (NDA) has been submitted to the FDA seeking an accelerated approval for lurbinectedin for use as a second-line treatment for patients with small cell lung cancer (SCLC), according to PharmaMar, the manufacturer of the investigational agent. The company reported in a press release that the NDA is based on results from a phase II basket trial in which lurbinectedin reached an overall response rate (ORR) of 35.2% as a … (leggi tutto)

FDA Approves Enzalutamide for Metastatic Castration-Sensitive Prostate Cancer

December 17, 2019 – The FDA has approved a supplemental new drug application for enzalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer. The approval is based on findings from the phase III ARCHES trial, in which the median radiographic progression-free survival (rPFS) in men with metastatic castration-sensitive prostate cancer was not reached with enzalutamide plus androgen deprivation therapy (ADT) and was 19.45 … (leggi tutto)

FDA Approval Sought for Ripretinib for Advanced GIST

December 16, 2019 – A new drug application (NDA) has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors (GIST) who have previously received treatment with imatinib, sunitinib, and regorafenib. The application is based on findings from the phase III INVICTUS trial, in which the investigational broad-spectrum KIT and PDGFR inhibitor ripretinib led to an 85% reduction in the … (leggi tutto)

Dall’ASCO

ASCO Applauds Congress for Raising Minimum Age to Purchase Tobacco and Boosting Cancer Research Funding

December 19, 2019 – “The American Society of Clinical Oncology (ASCO) applauds Congress for working across party lines to raise the minimum age for purchasing tobacco products to 21. A longtime advocate on this issue, ASCO believes this important change will delay and reduce the use of tobacco and help prevent tobacco-related cancers. A 2015 report from the Institute of Medicine predicted that raising the minimum age for the sale of tobacco products to 21 … (leggi tutto)

Giants of Cancer Care Inductee Announced as Next ASCO President

December 19, 2019 – Everett E. Vokes, MD, FASCO, who is a Giants of Cancer Care® recipient for Head and Neck Cancer, has been named the next president of ASCO for the 2021 to 2022 term. Additionally, Vokes, who is the John E. Ultmann Professor, chair of the Department of Medicine, and physician-in-chief at the University of Chicago Medicine and Biological Sciences, will take office as president-elect during the 2020 ASCO Annual Meeting in June. “It is a deep … (leggi tutto)

ASTRO Issues Clinical Guideline on Radiation Therapy for Basal Cell and Cutaneous Squamous Cell Carcinomas

December 18, 2019 – A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides recommendations on the use of radiation therapy to treat patients diagnosed with the most common types of skin cancers. The guideline details when radiation treatments are appropriate as stand-alone therapy or following surgery for basal cell and cutaneous squamous cell carcinomas, and it suggests dosing and fractionation for these treatments … (leggi tutto)

Ten Oncology Practices in Underserved Communities Receive Funding to Participate in Quality Improvement Programs

December 18, 2019 – Ten oncology practices from rural and urban centers in the U.S. that primarily treat underserved populations have received grant funding to participate in the American Society of Clinical Oncology’s (ASCO) Quality Oncology Practice Initiative (QOPI®) and Quality Training Program (QTP). ASCO announced today the recipients of the grants, which are supported by the Stavros Niarchos Foundation. The three-year grants, “Improving … (leggi tutto)

Everett E. Vokes, MD, FASCO, Elected ASCO President for 2021-2022 Term

December 17, 2019 – The American Society of Clinical Oncology (ASCO) has elected Everett E. Vokes, MD, FASCO, a long-time member and volunteer, to serve as its President for the term beginning in June 2021. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2020. Six new members were also elected to the ASCO Board of Directors and Nominating Committee. “It is a deep honor and privilege to be named President-Elect of … (leggi tutto)

Dal mondo

Frontline Pembrolizumab/Axitinib Approved in Japan for Advanced RCC

December 20, 2019 – Japan’s Pharmaceuticals and Medical Devices Agency has approved the combination of pembrolizumab and axitinib for the first-line treatment of patients with radically unresectable or metastatic renal cell carcinoma (RCC). The approval is based on results from the phase III KEYNOTE-426 trial, in which pembrolizumab combined with axitinib demonstrated statistically significant improvements in both progression- … (Leggi tutto)