Oggi in Oncologia
Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial
The phase III ACHIEVE trial conducted in Japan was one of six prospective studies included in the International Duration Evaluation of Adjuvant Therapy collaboration, which explored whether 3 months of adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CAPOX) therapy would be noninferior to 6 months of treatment in patients with curatively resected stage III colon cancer. We report the final analyses of survival and long-term safety … (leggi tutto)
Sono stati recentemente pubblicati su JCO i risultati delle analisi finali di sopravvivenza e sicurezza a lungo termine relative allo studio giapponese di fase III ACHIEVE. Si tratta di uno dei sei studi prospettici inclusi nella collaborazione internazionale per la valutazione della durata della terapia adiuvante, che ha esaminato se 3 mesi di terapia adiuvante con fluorouracile, leucovorin e oxaliplatino (FOLFOX) o capecitabina e oxaliplatino (CAPOX) siano non inferiori ai 6 mesi di trattamento nei pazienti con carcinoma del colon in stadio III operato con intento curativo.
I pazienti idonei sono stati assegnati in modo casuale (1:1) a 3 o 6 mesi di chemioterapia adiuvante ([m]FOLFOX6 o CAPOX modificato, a scelta del medico curante). L’assegnazione casuale è stata stratificata in base al numero di linfonodi coinvolti, al centro, al regime, al sito primario e all’età. L’endpoint primario era la sopravvivenza libera da malattia, valutata nella popolazione intention-to-treat. La sopravvivenza globale (OS) era un endpoint secondario.
La popolazione modificata intention-to-treat comprendeva 1.291 pazienti: 641 nel gruppo di trattamento di 6 mesi e 650 nel gruppo di trattamento di 3 mesi. Il follow-up mediano per questa analisi è stato di 74,7 mesi. I tassi di OS a cinque anni erano comparabili: 87,0% nel gruppo di trattamento a 3 mesi e 86,4% nel gruppo di trattamento a 6 mesi (hazard ratio, 0,91; IC 95%, 0,69-1,20; P = 0,51). L’analisi dei sottogruppi dell’OS non ha rivelato un’interazione significativa tra le caratteristiche di base e la durata del trattamento. La neuropatia periferica di durata superiore a 5 anni era più comune nel gruppo di trattamento di 6 mesi rispetto a 3 mesi (16% vs 8%, rispettivamente) e in quelli trattati con mFOLFOX6 rispetto a CAPOX (14% vs 11%, rispettivamente).
Nei pazienti asiatici, la riduzione della durata della terapia adiuvante da 6 a 3 mesi non ha compromesso l’efficacia e ha ridotto il tasso di neuropatia sensoriale periferica di lunga durata. Sulla base dei dati dello studio, 3 mesi di terapia con CAPOX rappresentano un’opzione di trattamento adiuvante appropriata.
COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non–Small-Cell Lung Cancer
Durvalumab significantly improves overall survival for patients with unresectable stage III non-small-cell lung cancer and no progression after concurrent chemoradiotherapy (cCRT). Building upon that standard of care, COAST is a phase II study of durvalumab alone or combined with the anti-CD73 monoclonal antibody oleclumab or anti-NKG2A monoclonal antibody monalizumab as consolidation therapy in this setting ... (leggi tutto)
Durvalumab ha dimostrato di migliorare significativamente la sopravvivenza globale per i pazienti con carcinoma polmonare non a piccole cellule in stadio III non resecabile e senza progressione dopo chemioradioterapia concomitante (cCRT). Basandosi su tale assunto, è stato sviluppato lo studio di fase II COAST, che testa durvalumab da solo o in combinazione con l’anticorpo monoclonale anti-CD73 oleclumab o l’anticorpo monoclonale anti-NKG2A monalizumab, come terapia di consolidamento in questo contesto.
I pazienti con carcinoma polmonare non a piccole cellule in stadio III non resecabile, ECOG performance status 0/1 e nessuna progressione dopo cCRT sono stati assegnati in modo casuale 1:1:1, ≤ 42 giorni dopo la cCRT, a durvalumab da solo o in combinazione con oleclumab o monalizumab fino a 12 mesi, stratificati per istologia. L’endpoint primario era il tasso di risposta obiettiva confermata valutata dallo sperimentatore (ORR; RECIST v1.1).
Tra gennaio 2019 e luglio 2020, 189 pazienti sono stati randomizzati. A questa analisi intermedia (cutoff dei dati, 17 maggio 2021), il follow-up mediano è stato di 11,5 mesi (intervallo, 0,4-23,4 mesi; tutti i pazienti). L’ORR confermato era numericamente più elevato con durvalumab più oleclumab (30,0%; IC 95%, 18,8-43,2) e durvalumab più monalizumab (35,5%; IC 95%, 23,7-48,7) rispetto a durvalumab (17,9%; IC 95%, 9,6-29,2). La sopravvivenza libera da progressione (PFS) è stata prolungata con entrambe le combinazioni rispetto a durvalumab (più oleclumab: hazard ratio, 0,44; IC 95%, 0,26-0,75; e più monalizumab: hazard ratio, 0,42; IC 95%, 0,24-0,72), con tassi di PFS più elevati a 12 mesi (più oleclumab: 62,6% [IC 95%, da 48,1 a 74,2] e più monalizumab: 72,7% [IC 95%, da 58,8 a 82,6] rispetto al solo durvalumab: 33,9% [IC 95%, da 21,2 a 47,1]). Eventi avversi emergenti dal trattamento di grado ≥ 3 per tutte le cause si sono verificati rispettivamente nel 40,7%, 27,9% e 39,4% di durvalumab più oleclumab, durvalumab più monalizumab e durvalumab.
Alla luce di quanto riportato dallo studio, entrambe le combinazioni hanno aumentato l’ORR e la PFS rispetto a durvalumab da solo. La sicurezza era simile tra i bracci senza problemi di sicurezza nuovi o significativi identificati con nessuna delle due combinazioni. Questi dati supportano pertanto una loro ulteriore valutazione in uno studio di fase III.
In Europa
EMA Recommends Extension of Therapeutic Indications for Atezolizumab
May 24, 2022 – On 22 April 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product atezolizumab (Tecentriq). The marketing authorisation holder for this medicinal product is Roche Registration GmbH. The CHMP adopted a new indication for the treatment of early-stage non-small cell lung cancer (NSCLC). … (leggi tutto)
HBV Infection Associated with Increased Risk of Primary Extrahepatic Malignancies
May 23, 2022 – The study that evaluated the associations of chronic hepatitis B and nucleos(t)ide analogue treatment with the risk of the development of extrahepatic malignancies point out to a need for more attention to the higher risk of extrahepatic malignancy in patients with chronic hepatitis B than in the general population. Long-term nucleos(t)ide analogue treatment was associated with lower risk of extrahepatic malignancy development among patients with chronic hepatitis B …. (leggi tutto)
Screen-Detected Colorectal Cancers Have a More Favourable Stage Distribution than Colorectal Cancers Detected Otherwise
May 20, 2022 – In a population-based study conducted in 9 European countries for which data on mode of detection were available (Belgium, Denmark, England, France, Italy, Ireland, the Netherlands, Slovenia, and Spain), the proportion of colorectal cancer cases detected by screening varied widely between countries. However, in all countries, screen-detected cancers had a more favourable stage distribution than cancers detected otherwise. …. (leggi tutto)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
May 20, 2022 – EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting. A recommendation for marketing authorisation was adopted for Cevenfacta (eptacog beta (activated)) for the treatment of bleeding episodes in patients with congenital haemophilia. The CHMP gave a positive opinion under exceptional circumstances for a new gene therapy, Upstaza* (eladocagene exuparvovec).X … (leggi tutto)
Dall’FDA
FDA Grants Priority Review to Mirvetuximab Soravtansine for FRα-High, Platinum-Resistant Ovarian Cancer
May 23, 2022 – The FDA has accepted and filed a biologics license application (BLA) for mirvetuximab soravtansine (IMGN853) for the treatment of patients with folate receptor alpha (FRα)–high, platinum-resistant ovarian cancer who have previously received between 1 and 3 systemic therapies. The application simultaneously received priority review designation. The BLA, which is based on findings from the pivotal phase 3 SORAYA trial (NCT04296890) … (leggi tutto)
FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
May 21, 2022 – The FDA has approved azacitidine (Vidaza) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). The regulatory decision is supported by data from the international, multicenter, open-label AZA-JMML-001 (NCT02447666), in which investigators examined the safety and efficacy of azacitidine vs historical controls in pediatric patients with newly diagnosed myelodysplastic syndrome or JMML before hematopoietic stem cell transplantation (HSCT) …. (leggi tutto)
FDA Places Partial Clinical Hold on Phase 1 Trial Evaluating FHD-286 in Relapsed/Refractory AML and MDS
May 20, 2022 – The FDA has placed a partial clinical hold on a phase 1 trial (NCT04891757) investigating FHD-286 as a treatment for patients with relapsed and/or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The partial hold was initiated following the report of a recent death of a patient who had potential differentiation syndrome. Differentiation syndrome is linked to AML/MDS therapeutics that induce differentiation … (leggi tutto)
FDA Grants Orphan Drug Designation to XMT-2056 for Gastric Cancer
May 19, 2022 – The FDA has granted an orphan drug designation to XMT-2056 for use as a potential therapeutic option for patients with gastric cancer, according to an announcement from Mersana Therapeutics. XMT-2056, an Immunosynthen STING-agonist antibody-drug conjugate (ADC), was created by leveraging a differentiated antibody that binds to a novel HER2 epitope, making it a treatment option as a single agent or in combination with other HER2-directed therapies … (leggi tutto)
Dall’ASCO
Mortality and Associated Factors Among Patients With Cancer vs No Cancer Infected With SARS–CoV-2
May 20, 2022 – In a systematic review and meta-analysis reported in JAMA Network Open, Khoury et al found that SARS–CoV-2 infection was associated with a higher risk of mortality among patients with cancer vs those without cancer. Risk vs those with no cancer was increased with younger age, and patients with lung cancer and hematologic cancer were at greatest risk … (leggi tutto)
Education Session to Review New Directions in Mantle Cell Lymphoma Treatment
May 19, 2022 -Although great progress has been made in the treatment landscape of mantle cell lymphoma (MCL), disease management still requires further optimization, and clinicians need updates on how to incorporate individual risk profiles into clinical decision-making and better tailor treatment strategies to improve clinical outcomes. An Education Session will include discussions on new and emerging strategies for treatment-naive patients with MCL … (leggi tutto)
Education Session Focuses on Latest Developments in Treating KRAS-Mutant Lung Cancer
May 19, 2022 – Mutated KRAS was once considered an undruggable target, but that changed with the May 2021 FDA approval of sotorasib for adult patients with advanced non–small cell lung cancer. The Education Session will discuss the history and challenges of treating KRAS mutations, the CodeBreaK 100 trial, and what’s next in the KRAS inhibitor pipeline. … (leggi tutto)
Education Sessions Highlight Strategies for Greater Trial Equity
May 19, 2022 – Several Education Sessions at this year’s Annual Meeting will discuss how patients with cancer can have equitable access to clinical trials. Sessions will focus on increasing participation of African populations, overcoming barriers to clinical trials, and developing clinical research networks in low- and middle-income countries. In late 2021, ASCO unveiled a new equity, diversity, and inclusion action plan aimed to infuse equity into all of the organization’s activities. … (leggi tutto)
CoVac-1 Vaccination Studied for Prevention of Severe COVID-19 in Immune-Deficient Patients With Cancer
May 17, 2022 – CoVac-1, a multipeptide COVID-19 vaccine candidate, elicited immunogenicity in patients with cancer and disease-related or treatment-related immunoglobulin deficiency in a phase I/II trial reported at the American Association for Cancer Research (AACR) Annual Meeting 2022.1 These patients are unable to mount an antibody immune response to existing vaccines that is sufficient for protection against COVID-19, including those with hematologic malignancies ... (leggi tutto)
Pillole dall’AIFA
23 maggio 2022 – Il Centro di coordinamento aggiorna i documenti per la parte II del Regolamento (UE) n. 536/2014
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20 maggio 2022 – Il Centro di coordinamento adotta il documento sulla valutazione delle indagini cliniche su dispositivi medici
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20 maggio 2022 – Report tecnico-scientifico AIFA su Libmeldy® (atidarsagene autotemcel)
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20 maggio 2022 – Aggiornamento “Diario di bordo sulla Trasparenza”
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19 maggio 2022 – Attivazione web e pubblicazione schede di monitoraggio – Registro ERLEADA (mHSPC)
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