AiomNews N. 920, 29 Agosto 2023

Oggi in Oncologia

Perioperative Nivolumab and Chemotherapy in Stage III Non-Small-Cell Lung Cancer

Approximately 20% of patients with non-small-cell lung cancer (NSCLC) receive a diagnosis of stage III disease. There is no current consensus regarding the most appropriate treatment for these patients. In this open-label, phase 2 trial, we randomly assigned patients with resectable stage IIIA or IIIB NSCLC to receive neoadjuvant nivolumab plus platinum-based chemotherapy (experimental group) or chemotherapy alone (control group), followed by surgery … (leggi tutto)

Circa il 20% dei pazienti affetti da Non-Small-Cell Lung Cancer (NSCLC) riceve una diagnosi in stadio III. Nello studio NADIM II, studio in aperto di fase II, Provencio et al. hanno randomizzato pazienti affetti da NSCLC in stadio IIIA e IIIB a ricevere trattamento neoadiuvante con nivolumab più combinazione di 2 farmaci chemioterapici a base di platino (gruppo sperimentale) oppure la sola chemioterapia (gruppo di controllo), seguito da chirurgia. I pazienti del gruppo sperimentale che sono stati sottoposti a chirurgia con margini negativi hanno successivamente ricevuto trattamento adiuvante con nivolumab per sei mesi.
Endpoint primario era la pathological complete response, endpoint secondari includevano la progression-free survival (PFS), l’overall survival (OS) a 24 mesi, e la safety.
Un totale di 86 pazienti è stato randomizzato; nel dettaglio, 57 sono stati assegnati al gruppo sperimentale e 29 al gruppo di controllo. Una pathological complete response è stata riportata nel 37% dei pazienti del gruppo sperimentale e nel 7% del gruppo di controllo (RR 5.34; 95% CI, 1.34-21.23; P = 0.02). Il 93% dei pazienti del gruppo sperimentale è stato sottoposto a chirurgia, contro il 69% nel gruppo di controllo (RR 1.35; 95% CI, 1.05-1.74). La PFS a 24 mesi è stata pari al 67.2% nel gruppo sperimentale vs 40.9% del gruppo di controllo (HR 0.47; 95% CI, 0.25-0.88). L’OS a 24 mesi è stata pari all’85% nel gruppo sperimentale e al 63.6% nel gruppo di controllo (HR 0.43; 95% CI, 0.19-0.98). Per quanto riguarda la safety, eventi avversi di grado 3 e 4 si sono verificati in 11 pazienti del gruppo sperimentale e in 3 pazienti del gruppo di controllo.
In conclusione, nei pazienti affetti da NSCLC stadio IIIA o IIIB il trattamento perioperatorio con nivolumab+chemioterapia ha evidenziato nel suddetto studio di fase II un maggior numero di risposte patologiche complete e una sopravvivenza più lunga rispetto al trattamento con la sola chemioterapia.

First-line cemiplimab monotherapy and continued cemiplimab beyond progression plus chemotherapy for advanced non-small-cell lung cancer with PD-L1 50% or more (EMPOWER-Lung 1): 35-month follow-up from a mutlicentre, open-label, randomised, phase 3 trial

Cemiplimab provided significant survival benefit to patients with advanced non-small-cell lung cancer with PD-L1 tumour expression of at least 50% and no actionable biomarkers at 1-year follow-up. In this exploratory analysis, we provide outcomes after 35 months’ follow-up and the effect of adding chemotherapy to cemiplimab at the time of disease progression … (leggi tutto)

Nel recente articolo pubblicato su Lancet Oncology da Rietschel et al, è stata presentata un’analisi esploratoria dell’EMPOWER-Lung 1. Gli autori hanno arruolato pazienti affetti da NSCLC avanzato con espressione del PD-L1 maggiore del 50%. I pazienti sono stati randomizzati a ricevere cemiplimab 350 mg q21 fino a 108 settimane, o fino a progressione di malattia, oppure a ricevere chemioterapia a scelta dello sperimentatore. Endpoint primario erano l’overall survival e la progression-free survival (PFS). I pazienti a progressione di malattia da cemiplimab avevano la possibilità di continuare il trattamento sperimentale con l’aggiunta di un massimo di 4 cicli di chemioterapia. Gli endpoint primari sono stati valutati su tutta la popolazione e nei pazienti con espressione del PD-L1 di almeno il 50%. Tra maggio 2017 e marzo 2020 sono stati arruolati un totale di 712 pazienti, 357 hanno ricevuto cemiplimab e 355 pazienti chemioterapia. Tra questi, 284 nel gruppo sperimentale e 281 nel gruppo di controllo presentavano un’espressione del PD-L1 maggiore del 50%. Ad un follow up mediano di 35 mesi, tra i pazienti con espressione del PD-L1 maggiore del 50%, l’overall survival mediana nel gruppo sperimentale è stata pari a 26.1 mesi versus 13.3 mesi nel gruppo di controllo (HR 0,57, 95% CI 0,46–0,71; p<0,0001). La PFS mediana è stata pari a 8.1 mesi nel gruppo con cemiplimab versus 5.3 mesi nel gruppo con chemioterapia (HR 0,51, 95% CI 0,42–0,62; p<0,0001). Il trattamento prolungato con cemiplimab con l’aggiunta della chemioterapia come seconda linea terapeutica è stato eseguito in un totale di 64 pazienti con una PFS mediana di circa 6.6 mesi e una OS di 15.1 mesi. Per quanto riguarda la safety, gli eventi avversi più frequenti sono stati anemia, neutropenia, polmonite. Si sono verificati un totale di 10 decessi correlati al trattamento nel gruppo sperimentale.
In conclusione, ad un follow up mediano di 35 mesi, l’impiego di cemiplimab come terapia di prima linea nei pazienti affetti da NSCLC avanzato con espressione di PDL1 superiore al 50% si conferma associato a un chiaro beneficio in sopravvivenza rispetto alla chemioterapia.

Atezolizumab, vemurafenib, and cobimetinib in patients with melanoma with CNS metastases (TRICOTEL): a multicentre, open-label, single-arm, phase 2 study

Targeted therapy and immunotherapy have shown intracranial activity in melanoma with CNS metastases, but there remains an unmet need, particularly for patients with symptomatic CNS metastases. We aimed to evaluate atezolizumab in combination with cobimetinib or vemurafenib plus cobimetinib in patients with melanoma with CNS metastases … (leggi tutto)

Targeted therapy e immunoterapia hanno mostrato efficacia intracranica nei pazienti affetti da melanoma con metastasi encefaliche. In questo studio pubblicato recentemente su Lancet Oncology da Dummer et al, gli autori hanno valutato atezolizumab in combinazione con cobimetinib o atezolizumab in combinazione con vemurafenib più cobimetinib in pazienti affetti da melanoma con metastasi encefaliche. TRICOTEL è uno studio multicentrico, in aperto, a braccio singolo, di fase II, suddiviso in due coorti: una includeva casi BRAF wild type e l’altra includeva casi BRAF mutati. I criteri di eleggibilità includevano pazienti con melanoma metastatico naïve al trattamento con metastasi encefaliche di 5 mm o maggiori, ed un PS di 1-2. I pazienti della coorte BRAF wild-type hanno ricevuto la somministrazione di atezolizumab intravenoso più cobimetinib; mentre i pazienti della coorte BRAF+ hanno ricevuto atezolizumab più vemurafenib e cobimetinib. Endpoint primario era l’objective response rate intracranica. A causa dell’interruzione prematura della coorte BRAF wild-type, l’endpoint primario non è stato raggiunto in tale coorte. Tra dicembre 2018 e dicembre 2020, sono stati arruolati 65 pazienti nella coorte BRAF+, mentre la coorte BRAF wild type è stata conclusa precocemente dopo il reclutamento di 15 pazienti. Ad un follow up mediano di 9.7 mesi per la coorte BRAF+ e di 6.2 mesi nella coorte BRAF wild type, l’IORR è stata del 42% nella coorte BRAF + e del 27% nell’altra coorte. Eventi avversi di grado 3 e maggiore si sono verificati sono stati aumento delle lipasi e CPK, anemia e dermatite acneiforme.
In conclusione, atezolizumab più cobimetinib e vemurafenib hanno evidenziato attività intracranica in pazienti con melanoma metastatico BRAF+.

Low Incidence of Local Recurrence When Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer

Aug 22, 2023 – The LUMINA study investigators showed that women 55 years of age or older with T1N0, grade 1 or 2, luminal A breast cancer have a very low risk of local recurrence at 5 years after breast-conserving surgery when treated with endocrine therapy alone. The prospective and controlled nature of this study supports conclusion that such patients are candidates for omission of radiotherapy. … (leggi tutto)

Panitumumab Added to Infusional Fluorouracil Plus Leucovorin May Be a Reasonable Initial Treatment Option for Elderly Patients with RAS/BRAF wild-type mCRC

Aug 21, 2023 – PANDA is a unique study specifically conducted in elderly patients with RAS/BRAF wild-type metastatic colorectal cancer (mCRC) fit enough to potentially receive first-line treatment with an anti-EGFR agent added to infusional chemotherapy backbone. Notably, the 5-fluorouracil (5-FU) bolus was omitted in both study arms to improve chemotherapy tolerability without loss of efficacy ... (leggi tutto)

Long-Term Efficacy of Single-Agent Neoadjuvant/Adjuvant PD1 Blockade for Resectable Cutaneous Melanoma in Patients with a pCR

Aug 16, 2023 – Five-year data from a phase Ib study represent the longest follow-up of a single-agent neoadjuvant PD1 treatment to date and confirm the efficacy of neoadjuvant/adjuvant single-agent PD1 blockade in the highest risk subset of patients with resectable cutaneous melanoma. Pathologic response to treatment remains prognostic, as patients with ≤10% viable tumour remaining had a 5-year overall survival (OS) of 100% ... (leggi tutto)

Zolbetuximab plus CAPOX Prolongs Survival in CLDN18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma

Aug 14, 2023 – In GLOW, a global, randomised, double-blind, phase III study, the addition of zolbetuximab to first-line treatment with CAPOX significantly improved progression-free survival (PFS) and overall survival (OS) compared to placebo plus CAPOX among the patients with claudin-18 isoform 2 (CLDN18.2)-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma … (leggi tutto)

A Positive Trend in OS Improvement Favours Atezolizumab Compared to Best Supportive Care in Stage II-IIIA Resected NSCLC, Primarily Driven by the PD-L1 TC ≥50% Subgroup

Aug 11, 2023 – While overall survival (OS) could not yet be formally tested in the intent-to- treat (ITT) population, the first interim analysis of OS with deaths in 25% of patients included in the IMpower010 study, showed OS improvement in favour of atezolizumab versus best supportive care (BSC) in the stage II-IIIA resected non-small cell lung cancer (NSCLC). The OS benefit with atezolizumab versus BSC was strongest in the stage II-IIIA PD-L1 TC ≥50% population ... (leggi tutto)

Adjuvant Everolimus Does Not Improve Recurrence-Free Survival Among Patients with Renal Cell Carcinoma

Aug 09, 2023 – EVEREST is the first reported study of an mTOR inhibitor as adjuvant treatment for renal cell carcinoma (RCC). Everolimus administered up to 1 year after surgery did not improve recurrence-free survival (RFS) compared with placebo in the overall study population. Subgroup analysis by risk group stratification suggested a RFS benefit with everolimus among patients with very high risk disease, but no benefit among those with intermediate-high risk disease … (leggi tutto)

Revocation of authorisation for sickle cell disease medicine Adakveo

Aug 09, 2023 – On 26 May 2023, EMA’s human medicines committee (CHMP) recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease. This followed a review by the CHMP, which concluded that the benefits of the medicine did not outweigh its risks. The review looked at results of the STAND study ... (leggi tutto)

Niraparib Plus Abiraterone Acetate and Prednisone Improves rPFS and Other Clinically Relevant Outcomes in First-Line Treatment for Patients with mCRPC

Aug 08, 2023 – Longer follow-up from the second prespecified interim analysis of the MAGNITUDE study that enroled the largest BRCA1/2 cohort in first-line setting of patients with metastatic castration-resistant prostate cancer (mCRPC) to date, demonstrate improved radiographic progression-free survival (rPFS), time to symptomatic progression, and time to initiation of cytotoxic chemotherapy with niraparib plus abiraterone acetate and prednisone in patients with BRCA1/2-altered ... (leggi tutto)

HER2 Expression is a Determinant of Sensitivity to Trastuzumab Deruxtecan in Metastatic Breast Cancer, Although Other Mechanisms May Be Involved

Aug 07, 2023 – The phase II DAISY study evaluated the efficacy of an anti-HER2 drug conjugate, trastuzumab deruxtecan (T-DXd) in patients with metastatic breast cancer with variable HER2 expression: HER2-overexpressing, HER2-low and HER2 non-expressing cancers. The study suggests that HER2 is a determinant of sensitivity to T-DXd, although modest antitumour activity was also observed in a small subset of patients whose cancer did not express HER2 … (leggi tutto)

Camrelizumab Plus Rivoceranib Improves Survival Compared with Sorafenib in First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Aug 02, 2023 – CARES-310 is the first phase III study to report significant benefits in both progression-free survival (PFS) and overall survival (OS) with the combination of an anti-PD1/PD-L1 antibody and an orally administered, small-molecule tyrosine kinase inhibitor (TKI) over standard TKI for unresectable hepatocellular carcinoma in the first-line setting. The dual primary endpoints were met with camrelizumab plus rivoceranib ... (leggi tutto)

Aug 25, 2023 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the signing of a first-of-its kind Regulatory Partnership Arrangement with Ecuador’s seafood regulatory authority to enhance the safety of shrimp imported to the United States. On Thursday, the FDA issued a proposedExternal Link Disclaimer rule to revise the standard of identity and standard … (leggi tutto)

FDA Grants Fast Track Status to ALE.C04 for Recurrent or Metastatic CLDN1+ HNSCC

Aug 25, 2023 – The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1 (CLDN1)–positive head and neck squamous cell carcinomas (HNSCC).The first-in-class monoclonal antibody was designed with an effector function that directly targets the cancer, silences carcinogenic signaling that is mediated by CLDN1, and opens the extracellular matrix (ECM) … (leggi tutto)

Aug 11, 2023 – The FDA has approved a study may proceed letter in advance of its 30-day review period to Oncternal Therapeutics for its phase 1/2 dose-escalation study (NCT05917470) evaluating ONCT-534, a novel dual-action androgen receptor inhibitor (DAARI) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor signaling inhibitors (ARSIs) … (leggi tutto)

FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer

Aug 09, 2023 – The FDA has issued a complete response letter (CRL) to the new drug application (NDA) seeking the approval of avasopasem manganese (GC4419) as a treatment for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment. The regulatory agency ruled that data from the phase 3 ROMAN (NCT03689712) and phase 2b GT-201 (NCT02508389) trials did not sufficiently demonstrate … (leggi tutto)

Aug 09, 2023 – The FDA has granted regular approval to pralsetinib (Gavreto) for adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In September 2020, the regulatory agency had granted accelerated approval to the agent for this indication based on findings on overall response rate (ORR) and duration of response (DOR) from the phase 1/2 ARROW trial (NCT03037385) … (leggi tutto)

Aug 08, 2023 – The FDA has granted orphan drug designation to LSTA1 (CEND-1) for use as a potential therapeutic option in patients with malignant glioma, according to an announcement from Lisata Therapeutics, Inc. LSTA1 was designed to target tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumors but not in healthy tissues. … (leggi tutto)

FDA Grants Orphan Drug Designation to ABM-1310 for BRAF V600–Mutant Glioblastoma

Aug 03, 2023 – The FDA has granted an orphan drug designation to ABM-1310 for the treatment of patients with BRAF V600–mutant glioblastoma, according to an announcement from ABM Therapeutics. ABM-1310 is an oral, selective BRAF inhibitor that has high water solubility, and high blood–brain barrier permeability. The agent is under evaluation in phase 1 trials in the United States and China for patients with BRAF V600–mutant advanced solid tumors … (leggi tutto)

FDA Approves Trifluridine/Tipiracil Plus Bevacizumab in Previously Treated Metastatic Colorectal Cancer

Aug 02, 2023 – The FDA has approved trifluridine and tipiracil (Lonsurf) plus bevacizumab (Avastin) for patients with metastatic colorectal cancer (mCRC) who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; a VEGF inhibitor; and an EGFR inhibitor, if they have RAS wild-type disease. The regulatory decision is supported by data from the phase 3 SUNLIGHT trial (NCT04737187), in which the combination significantly improved … (leggi tutto)

FDA Grants Orphan Drug Designation to Elraglusib for Pancreatic Cancer

Aug 01, 2023 – The FDA has granted orphan drug designation to the GSK-3β inhibitor, elraglusib (9-ING-41), for the treatment of patients with pancreatic cancer, according to an announcement from Actuate Therapeutics, Inc.The safety and efficacy of the agent as a monotherapy and in combination with cytotoxic agents is being explored in patients with refractory cancers as part of an ongoing phase 1/2 1801 trial (NCT03678883) … (leggi tutto)

Dr. Dionisia Quiroga on Leveraging Surgery to Mitigate Lymphedema and Improve Pain Management for Patients

Aug 24, 2023 – For patients with breast cancer, the effects of lymphedema can have a profound impact on quality of life. Fluid build-up in the arms and legs due to damaged lymph vessels can cause painful swelling and inflammation that affects patients during and after treatment. By flushing connective lymph vessels—previously damaged during cancer therapies—to nearby veins, surgical interventions can provide essential relief by draining built-up fluids from … (leggi tutto)

Aug 24, 2023 – Yoga is a mind–body practice that not only incorporates movement and stretching but includes controlled breathing practices, relaxation, and meditation.
Yoga therapy is the process of empowering individuals to progress toward improved health and well-being through the application of the teachings and practices of yoga.
Clinical practice guidelines support the use of yoga practices to help patients with cancer manage fatigue and nausea and to help … (leggi tutto)

Aug 23, 2023 – Sequential androgen receptor signaling inhibitor (ARSI) use has demonstrated limited efficacy in most patients with advanced metastatic castration-resistant prostate cancer. Progression on ARSIs is associated with cross-resistance resulting from AR-dependent and AR-independent mechanisms. Use of ARSIs following progression on a prior agent should entail careful decision-making, weighing the risks and benefits of this strategy … (leggi tutto)

What is the Potential Role of PARP Inhibitors for Metastatic Breast Cancer With a Germline PALB2 Pathogenic Variant?

Aug 23, 2023 – Olaparib and talazoparib have been approved for the treatment of germline BRCA1/2 mutation carriers with metastatic HER2-negative breast cancer.
The phase 2 TBCRC-048 study confirmed high response rates in patients with advanced breast cancer with germline PALB2 and somatic BRCA1/2 mutations receiving olaparib. Because of the low frequency of the PALB2 mutation, dedicated studies may not be feasible, but real-world … (leggi tutto)

Considering Adjuvant CDK4/6 Inhibitors?: monarchE and NATALEE in Clinical Practice

Aug 17, 2023 – The NATALEE and monarchE studies looked at adjuvant CDK4/6 inhibitors ribociclib and abemaciclib, respectively, as options for hormone receptor–positive early breast cancer. In monarchE, abemaciclib improved 2-year invasive disease-free survival (IDFS; ∆3.5%, 92.2% vs 88.7%) and 4-year IDFS (∆6.4%; 85.8% vs 79.4%), and in NATALEE, ribociclib improved 3-year IDFS (∆ 3.3%; 90.4% vs 87.1%) … (leggi tutto)

TALAPRO-2 in Practice: Considering Talazoparib Plus Enzalutamide For Patients With mCRPC and HRR Mutations

Aug 17, 2023 – HRR alterations are frequent (∼25%) and have prognostic and predictive value in metastatic castration-resistant prostate cancer (mCRPC). In the phase 3 trial TALAPRO-2, the addition of the PARP inhibitor talazoparib to approved standard-of-care enzalutamide significantly prolonged rPFS (primary endpoint) as well as other endpoints, such as time to prostate-specific antigen progression … (leggi tutto)

Aug 16, 2023 – Although the brain–computer interface (BCI) is relatively new to oncology, various forms have shown promise in alleviating symptoms resulting from cancer or cancer treatment. To take advantage of BCI, oncologists and other clinicians must have a basic knowledge of the technology and areas in which it could help patients. … (leggi tutto)

Early-Stage Cancer Diagnoses in the United States May Have Decreased During the First Year of the COVID-19 Pandemic

Aug 3, 2023 – Investigators have found that monthly U.S. adult cancer diagnoses decreased by 50% early in April 2020 and that the largest decreases were observed for stage I tumors, resulting in a higher proportion of late-stage cancer diagnoses, according to a recent study published by Han et al in The Lancet Oncology. The findings may offer new insights into the impact that the first year of the COVID-19 pandemic had on cancer diagnoses and staging in the United States … (leggi tutto)

Pillole dall’AIFA

28 agosto 2023 – Caos e pandemia: su PLOS ONE uno studio sull’evoluzione dei coronavirus emergenti. Palù: “aiuterà la sanità pubblica nel controllo delle future emergenze pandemiche”
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25 agosto 2023 – Aggiornamento “Diario di bordo sulla Trasparenza”
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21 agosto 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro AMVUTTRA
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17 agosto 2023 – Chiusura Registro di monitoraggio SIGNIFOR
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17 agosto 2023 – Revisione EMA dei dati sull’esposizione paterna al valproato
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16 agosto 2023 – Nota Informativa Importante sul dispositivo BAXJECT II confezionato insieme al medicinale Recombinate
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11 agosto 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro OPDIVO CHEMIOTERAPIA – ESCC
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10 agosto 2023 – Farmaci biosimilari in Italia: report AIFA aggiornati ad aprile 2023
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9 agosto 2023 – Attivazione web e pubblicazione schede di monitoraggio – Registro KYMRIAH (LF)
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9 agosto 2023 – Nota Informativa Importante su Simponi (golimumab)
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7 agosto 2023 – AIFA pubblica il Rapporto Nazionale 2022 “L’uso dei Farmaci in Italia”
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4 agosto 2023 – Sperimentazioni cliniche in Italia: i dati del triennio 2020-2022
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