Roche reports update on Phase III SKYSCRAPER-01 study results
Roche reports that the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® versus Tecentriq alone in PD-L1-high non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoint of overall survival at final analysis. The global, randomized, double-blind study involved 534 patients with previously untreated, locally advanced unresectable or metastatic NSCLC. The safety profile remained consistent with longer follow-up, showing no new safety signals. Detailed data will be presented at a medical meeting in 2025.
Roche riporta che lo studio di fase III SKYSCRAPER-01, che valuta tiragolumab combinato con Tecentriq® rispetto a Tecentriq da solo in pazienti con cancro polmonare non a piccole cellule (NSCLC) ad alto PD-L1, non ha raggiunto il suo obiettivo primario di sopravvivenza globale nell'analisi finale. Lo studio globale, randomizzato e in doppio cieco ha coinvolto 534 pazienti con NSCLC localmente avanzato, non resecabile o metastatico, non trattati in precedenza. Il profilo di sicurezza è rimasto coerente con un follow-up più lungo, senza segnali di sicurezza nuovi. Dati dettagliati saranno presentati in un incontro medico nel 2025.
Roche informa que el estudio de fase III SKYSCRAPER-01, que evalúa tiragolumab combinado con Tecentriq® frente a Tecentriq solo en pacientes con cáncer de pulmón no microcítico (NSCLC) con alta PD-L1, no alcanzó su objetivo primario de supervivencia global en el análisis final. El estudio global, aleatorizado y doble ciego involucró a 534 pacientes con NSCLC localmente avanzado, no resecable o metastásico, que no habían recibido tratamiento previo. El perfil de seguridad se mantuvo consistente con un seguimiento más largo, sin nuevas señales de seguridad. Los datos detallados se presentarán en una reunión médica en 2025.
로슈는 PD-L1이 높은 비소세포 폐암(NSCLC) 환자에서 테센트릭과 Tecentriq®와 병용한 티라골루맙을 평가하는 3상 SKYSCRAPER-01 연구가 최종 분석에서 전체 생존율의 주요 목표를 달성하지 못했다고 보고합니다. 전 세계적으로 무작위, 이중맹검 연구에는 이전에 치료받지 않은 534명의 국소 진행형 절제가 불가능하거나 전이성 NSCLC 환자가 포함되었습니다. 안전성 프로필은 더 긴 추적 조사에서도 일관되게 유지되었으며 새로운 안전 신호는 나타나지 않았습니다. 자세한 데이터는 2025년 의료 회의에서 발표될 예정입니다.
Roche rapporte que l'étude de phase III SKYSCRAPER-01, évaluant le tiragolumab en combinaison avec Tecentriq® par rapport à Tecentriq seul chez des patients atteints de cancer du poumon non à petites cellules (NSCLC) à PD-L1 élevé, n'a pas atteint son objectif principal de survie globale lors de l'analyse finale. L'étude mondiale, randomisée et en double aveugle, a impliqué 534 patients atteints de NSCLC localement avancé, non résécable ou métastatique, n'ayant pas été traités auparavant. Le profil de sécurité est resté cohérent lors d'un suivi prolongé, sans nouveaux signaux de sécurité. Des données détaillées seront présentées lors d'une réunion médicale en 2025.
Roche berichtet, dass die Phase-III-Studie SKYSCRAPER-01, die Tiragolumab in Kombination mit Tecentriq® im Vergleich zu alleiniger Gabe von Tecentriq bei Patienten mit PD-L1-hohem nicht-kleinzelligem Lungenkrebs (NSCLC) evaluiert, ihr primäres Ziel der Gesamtüberlebensrate in der Abschlussanalyse nicht erreicht hat. Die globale, randomisierte, doppelblinde Studie umfasste 534 Patienten mit zuvor unbehandeltem, lokal fortgeschrittenem, nicht operablem oder metastasierendem NSCLC. Das Sicherheitsprofil blieb bei längerer Nachverfolgung konsistent und zeigte keine neuen Sicherheitssignale. Detaillierte Daten werden 2025 auf einer medizinischen Tagung präsentiert.
- Safety profile remained consistent with no new safety concerns
- Failed to meet primary endpoint of overall survival in Phase III SKYSCRAPER-01 study
- Combination therapy of tiragolumab with Tecentriq showed no superiority over Tecentriq alone
Basel, 26 November 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) reports an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).
SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.
Roche continuously reviews its study programmes to determine if any adjustments are necessary for the purposes of ongoing research. Roche will apply the same principles to this programme, with additional data from phase III studies across different settings or tumour types anticipated next year.
About tiragolumab
Tiragolumab is an investigational immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1
About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
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