AiomNews N. 953, 30 aprile 2024

Oggi in Oncologia

Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer

Background: Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking. Methods: We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA … (leggi tutto)

La chemioterapia a base di platino nel setting adiuvante è attualmente raccomandata per il trattamento di pazienti affetti da NSCLC resecabile.
Lo studio globale open-label, randomizzato, di fase III ALINA ha voluto valutare l’efficacia e la sicurezza in questo setting di alectinib (inibitore tirosinchinasico di ALK) rispetto alla chemioterapia standard a base di platino e vinorelbina, gemcitabina o pemetrexed, nel trattamento del NSCLC, ALK positivo in stadio IB, II o IIIA, completamente resecato chirurgicamente e non pretrattato con altri regimi di chemioterapia.
I pazienti sono stati randomizzati (1:1) a ricevere alectinib in somministrazione orale ad un dosaggio di 600 mg, 2 volte al giorno per 24 mesi (salvo progressione di malattia, tossicità inaccettabile o discontinuazione da parte del paziente) o chemioterapia endovena a base di platino, ogni 21 giorni per 4 cicli. Le opzioni di chemioterapia erano cisplatino alla dose di 75 mg/m² nel giorno 1 di ciascun ciclo, più vinorelbina alla dose di 25 mg/m² (giorni 1 e 8); gemcitabina alla dose di 1250 mg/m² (giorni 1 e 8) o pemetrexed alla dose di 500 mg/m² (giorno 1). Nel caso di intolleranza al cisplatino, veniva somministrato carboplatino AUC 5 o 6. I pazienti sono stati stratificati in accordo a stadio di malattia (IB vs II vs IIIA) ed etnia (asiatica o non asiatica).
Endpoint primario dello studio era la disease free survival (DFS). Endpoint secondari erano overall survival (OS) e sicurezza. Un altro endpoint era la DFS a carico del sistema nervoso centrale.
In totale, 257 pazienti sono stati arruolati tra Agosto 2018 e Dicembre 2021: 130 pazienti hanno ricevuto alectinib e 117 pazienti hanno ricevuto chemioterapia. La DFS a 2 anni è stata pari al 93.6% nel gruppo alectinib e 63.7% nel gruppo chemioterapia; il tasso di DFS a 3 anni era dell’88.7% e del 54%, rispettivamente.
Eventi avversi più comuni, di grado 1 o 2, sono stati: aumento dei livelli di creatinchinasi e stipsi nel gruppo alectinib, nausea ed iporessia nel gruppo chemioterapia. Eventi avversi che hanno portato alla discontinuazione del farmaco sono stati riportati nel 5.5% dei pazienti del gruppo alectinib e nel 12.5% di quelli del gruppo chemioterapia.
Alectinib nel setting adiuvante ha pertanto dimostrato superiorità in termini di DFS rispetto alla chemioterapia, così come un miglior profilo di sicurezza e un minor tasso di discontinuazioni di terapia per effetti collaterali. Alectinib in adiuvante rappresenta una nuova importante strategia terapeutica per pazienti affetti da NSCLC ALK-positivo in stadio precoce (IB, II o IIIA), completamente resecato. Questo significa che anche nella malattia in stadio precoce, completamente resecata, una profilazione molecolare comprendente PDL1, EGFR e ora anche Alk è da effettuarsi per poter fornire un’indicazione terapeutica e prognostica adeguata ai pazienti.

Osimertinib plus local treatment for brain metastases versus osimertinib alone in patients with EGFR-Mutant Non-Small Cell Lung Cancer

Objectives: Osimertinib is a standard treatment for patients with EGFR-mutant non-small cell lung cancer (NSCLC) and is highly effective for brain metastases (BMs). However, it is unclear whether local treatment (LT) for BMs prior to osimertinib administration improves survival in EGFR-mutant NSCLC. We aimed to reveal the survival benefit of upfront local treatment (LT) for BMs in patients treated with osimertinib … (leggi tutto)

Nei pazienti affetti da NSCLC con mutazione EGFR, gli inibitori della tirosin-chinasi migliorano la PFS rispetto alla chemioterapia standard. In particolare, osimertinib ha evidenziato un’elevata capacità di penetrazione della BEE rispetto agli altri EGFR-TKIs e, quindi, una maggiore efficacia sulle metastasi cerebrali. Tuttavia, non è chiaro se e quanto un trattamento locale sulle metastasi cerebrali prima dell’inizio della terapia con osimertinib possa migliorarne la sopravvivenza.
Questo studio multicentrico e retrospettivo, si prefiggeva di dimostrare il beneficio, in termini di sopravvivenza, del trattamento radiante sulle metastasi cerebrali in pazienti affetti da NSCLC, con mutazione EGFR trattati con osimertinib rispetto al solo trattamento con lo stesso farmaco.
In nove centri giapponesi, sono stati arruolati pazienti con NSCLC EGFR mutato e metastasi cerebrali accertate con esame TC o RM e che avevano ricevuto un trattamento di prima linea con osimertinib tra Agosto 2018 ed Ottobre 2021.
Dei 121 pazienti arruolati, 45 avevano ricevuto trattamento con osimertinib + radioterapia delle metastasi cerebrali mentre 73 avevano ricevuto soltanto osimertinib. I due più comuni tipi di mutazione riscontrati a carico di EGFR sono stati la delezione dell’esone 19 nel 47% dei pazienti e la mutazione dell’esone 21 (L858R) nel 53%. Il 31% aveva una singola metastasi.
Ad un follow up mediano di 26.3 mesi (95 % CI, 21.2–28.9), l’OS del gruppo sottoposto ad iniziale trattamento locale era più lunga rispetto a quella del gruppo trattato con solo osimertinib (mediana, [NR] [95 %CI, NR–NR] vs 31.2 mesi [95 %CI, 21.7–33.3], p = 0.021). Anche la PFS a livello cerebrale si è rivelata migliore nei pazienti trattati con radioterapia cerebrale ed osimetinib (mediana, NR [95 % CI, 39.8–NR] vs NR [95 %CI, 18.6–NR], p = 0.030).
Gli eventi avversi di grado ≥ 3 (principalmente neutropenia, vomito e/o diarrea, tossicità cutanea, ILD) si sono verificati in 6 (13,3%) pazienti nel gruppo di trattamento locale e in 15 (19,7%) nel gruppo con osimertinib in monoterapia.
Questo studio presenta alcuni limiti: in primo luogo, le decisioni in merito all’approccio terapeutico delle metastasi cerebrali sono state prese da medici diversi in ciascun centro a causa della natura retrospettiva dello studio; l’indicazione ad effettuare anticipatamente il trattamento locale è stata influenzata dalla presenza di sintomi e dalla necessità di un trattamento con steroidi, oltre che dalle dimensioni delle metastasi cerebrali. Non è stata inoltre considerata la diffusione di malattia extracranica, che ovviamente contribuisce a definire l’OS. Infine, non è stata valutata la tossicità della radioterapia nel lungo termine.
Pertanto, nonostante i dati di combinazione appaiano impattanti sia sul controllo locale che sull’andamento di malattia, è certamente auspicabile uno studio prospettico con un più lungo follow up.

Apr 29, 2024 – On 25 April 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product capivasertib (Truqap), intended for the treatment of locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations. … (leggi tutto)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024

Apr 26, 2024 – Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa) … (leggi tutto)

Apr 26, 2024 – EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products … (leggi tutto)

A Deep-Learning Model Predicts the Primary System Origin of Malignant Cells Residing in Hydrothorax and Ascites from Patients with CUP

Apr 26, 2024 – A deep-learning model, developed on cytology images of hydrotorax and ascites from 57220 cases with cancer of unknown primary (CUP) managed at four tertiary hospitals, shows high accuracy in tumour origin prediction and presents prognostic value when patient treatment is consistent with the cancer origin predicted by the model. This method for tumour origin differentiation using cytological histology (TORCH) can serve … (leggi tutto)

FDA Approves Nogapendekin Alfa Inbakicept-pmln for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

Apr 26, 2024 – On 22 April 2024, the US Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours. Efficacy was evaluated in QUILT-3.032 (NCT0302285), a single-arm … (leggi tutto)

FDA Approves Alectinib as Adjuvant Treatment for ALK-positive Non-Small Cell Lung Cancer

Apr 25, 2024 – On 18 April 2024, the US Food and Drug Administration (FDA) approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumour resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. Efficacy was demonstrated in a global, randomised, open-label study (ALINA, NCT03456076) in patients … (leggi tutto)

Adjuvant Pembrolizumab Improves Overall Survival Among Patients with Clear-Cell Renal Cell Carcinoma Who Are At Increased Risk for Disease Recurrence After Nephrectomy

Apr 24, 2024 – After a median follow-up of 57.2 months, the KEYNOTE-564 study showed a significant and a clinically meaningful improvement in overall survival (OS) with an adjuvant treatment with pembrolizumab; pembrolizumab was associated with a 38% lower risk of death than placebo among patients with clear cell renal cell carcinoma (ccRCC) who were at increased risk for disease recurrence after surgery .. (leggi tutto)

Apr 29, 2024 – The FDA has granted full approval to tisotumab vedotin-tftv (Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.¹ The regulatory decision was supported by data from the phase 3 innovaTV 301 trial (NCT04697628), which showed that patients treated with tisotumab vedotin (n = 253) experienced a median overall survival (OS) … (leggi tutto)

FDA Approves Trastuzumab-strf for HER2-Overexpressing Breast and Gastric/GEJ Cancer

Apr 29, 2024 – The FDA has approved trastuzumab-strf (HLX02; Hercessi), a trastuzumab (Herceptin) biosimilar as adjuvant therapy for patients with HER2-overexpressing breast cancer, and as treatment for patients with HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.¹ … (leggi tutto)

Apr 26, 2024 – Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research … (leggi tutto)

FDA Grants Fast Track Designation to CTX-009 Plus Paclitaxel for Pretreated Biliary Tract Cancer

Apr 25, 2024 – The FDA has granted fast track designation to CTX-009, a bispecific DLL4/VEGF-A antibody in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract cancer following prior therapy.¹ “We are delighted that CTX-009 has received FDA fast track designation, highlighting the large unmet need in patients with advanced biliary tract cancer where current therapies have low, single-digit response rates … (leggi tutto)

Dostarlimab/Chemo Receives FDA Priority Review for Expanded Indication in Endometrial Cancer

Apr 24, 2024 – The FDA has granted priority review to the supplemental biologics license application (sBLA) seeking the expanded indication of dostarlimab-gxly (Jemperli) plus chemotherapy for the treatment of all adult patients with primary advanced or recurrent endometrial cancer, including patients with mismatch repair–proficient (pMMR)/microsatellite stable (MSS) disease.¹ … (leggi tutto)

FDA Grants Accelerated Approval to Tovorafenib for Pediatric Relapsed/Refractory BRAF+ Low-Grade Glioma

Apr 23, 2024 – The FDA has granted accelerated approval to tovorafenib (Ojemda) for the treatment of pediatric patients 6 months of age and older with relapsed or refractory low-grade glioma harboring a BRAF fusion or rearrangement, or a BRAF V600 mutation. This approval marks the first systemic therapy indicated for pediatric patients with low-grade glioma harboring BRAF rearrangements, including fusions … (leggi tutto)

Apr 23, 2024 -The FDA has approved lutetium Lu 177 dotatate (Lutathera) for the treatment of pediatric patients 12 years of age and older with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.¹ The approval was supported by pharmacokinetic, dosimetry, and safety data from the phase 2 NETTER-P trial (NCT04711135) … (leggi tutto)

Apr 23, 2024 – 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 a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people’s lives and may … (leggi tutto)

MASCC-ASCO Publish New Standards and Recommendations for Survivorship Care in Advanced Cancer

Apr 29, 2024 – These standards and practice recommendations for survivorship care were developed to address existing gaps and to help promote clinical care, research, and policy specifically targeting the growing population of people affected by advanced or metastatic cancer. Standards emphasize person-centered care, coordinated and integrated care, evidence-based and comprehensive care, and more … (leggi tutto)

Apr 25, 2024 – Liquid biopsies and other circulating tumor DNA (ctDNA) tests to detect multiple cancers at a very early stage could potentially radically change cancer diagnosis and treatment. No tests with complete accuracy are currently available, and a false positive could also lead to invasive screening of potentially unnecessary treatment. An 2024 ASCO Annual Meeting session will explore what it will take for these tests to be ready for prime time … (leggi tutto)

What’s New and What’s Next in Systemic Therapy Options for Breast Cancer

Apr 25, 2024 – Oncologists who specialize in breast cancer know that new therapies and modifications to existing therapies are developed every year, making staying informed on the latest treatments a necessity. An Education Session will spotlight updates on neoadjuvant strategies, tailored adjuvant therapy, and sequencing of therapy for metastatic breast cancer. Faculty will discuss important recent clinical trial data … (leggi tutto)

Apr 25, 2024 – The 2024 ASCO Annual Meeting will cover state-of-the-art research, groundbreaking treatments, and visionary insights that will ignite your passion for oncology. This year’s program will feature more than 200 sessions complementing this year’s Presidential theme, “The Art and Science of Cancer Care: From Comfort to Cure,” developed by 2023-2024 ASCO President Lynn M. Schuchter, MD, FASCO, of Penn Medicine … (leggi tutto)

Apr 25, 2024 – Social media is an essential component of the ASCO Annual Meeting experience, providing a vibrant channel for connection and collaboration with the global oncology community. ASCO will provide live updates on key research and onsite happenings in various formats, and attendees are encouraged to join the conversation. Before the Meeting, review the ASCO-related handles and hashtags (Table 1). These will be the best way to stay in the know. … (leggi tutto)

Mental Health and Cognitive Toxicities of Androgen Receptor Signaling Inhibitors

Apr 25, 2024 – Androgen receptor signaling inhibitors (ARSIs) are widely used across the spectrum of advanced prostate cancers. Evidence suggests they may be associated with an increased risk of depression and cognitive impairment. For men who have preexisting depression or cognitive impairment, the choice of ARSI may matter (eg, choosing abiraterone instead of enzalutamide) … (leggi tutto)

Apr 25, 2024 – TThe 2024 ASCO Annual Meeting is funded through Conquer Cancer®, the ASCO Foundation, by these generous donors. MISSION ENDOWMENT DONORS Founding Donors … (leggi tutto)

In-Hospital Mortality Among Patients With COVID-19 Infection, With or Without Cancer

Apr 24, 2024 – In a UK-based prospective cohort study reported in The Lancet Oncology, Turtle et al found that among patients hospitalized due to COVID-19 infection, those receiving cancer treatment had a higher rate of in-hospital mortality vs those without a cancer diagnosis. Study Details The study included data from patients aged > 19 years admitted to 306 health-care facilities in the United Kingdom with confirmed SARS–CoV-2 infection who were enrolled … (leggi tutto)

Pillole dall’AIFA

29 aprile 2024 – Tabelle farmaci di classe A e H al 15/11/2023
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26 aprile 2024 – Aggiornamento “Diario di bordo sulla Trasparenza”
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24 aprile 2024 – Monitoraggio della spesa farmaceutica (gennaio – novembre 2023)
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