Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer (mCRC) who have progressed after standard therapies Axel Grothey, MD Co-investigators: Alberto Sobrero, Salvatore Siena, Alfredo Falcone, Marc Ychou, Heinz-Josef Lenz, Takayuki Yoshino, Frank Cihon, Andrea Wagner, Eric Van Cutsem T: Patients with metastatic colorectal cancer treated with regoraf placebo after failure of standard therapy
Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer (mCRC) who have progressed after standard therapies. Axel Grothey , MD. - PowerPoint PPT Presentation
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Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT)of regorafenib plus best supportive care (BSC)
versus placebo plus BSC in patients with metastatic colorectal cancer (mCRC) who have
progressed after standard therapies
Axel Grothey, MD
Co-investigators:
Alberto Sobrero, Salvatore Siena, Alfredo Falcone, Marc Ychou,Heinz-Josef Lenz, Takayuki Yoshino, Frank Cihon,
Andrea Wagner, Eric Van Cutsem
CORRECT: Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy
Standard management of mCRC• Globally, 1,234,000 new CRC cases and 608,000 deaths each year1
– Vast majority of patients with mCRC are in a palliative situation2
• Standard medical treatment options:2
– 5-Fluorouracil + folinic acid/leucovorin or capecitabine– Oxaliplatin– Irinotecan– Bevacizumab – Cetuximab or panitumumab for KRAS wild-type CRC
• No standard salvage therapy, although many patients long retain good performance status
High unmet clinical need for active salvage therapy!
Primary endpoint met prespecified stopping criteria at interim analysis (1-sided p<0.009279 at approximately 74% of events required for final analysis)
– Progression-free survival: 1.9 vs 1.7 months, HR=0.49, p<0.000001
– Disease control rate (PR + SD): 44.8% vs 15.3%, p<0.000001
• No new or unexpected safety findings:
– Main treatment-related adverse events observed in the regorafenib arm were fatigue, hand–foot skin reaction, diarrhea, anorexia, voice changes, hypertension, oral mucositis, and rash/desquamation
Conclusions
• Regorafenib:– Increases overall survival vs placebo in patients with mCRC
progressing after standard therapies
– First small-molecule multi-kinase inhibitor with proof of efficacy in CRC
– Potential new standard of care in this patient population
• CORRECT demonstrates that:– We can accrue to placebo-controlled trials in a patient population with
an unmet need
– Refractory CRC is a realistic setting for drug development
Thanks to the investigating centersand study participants
Lead investigators: AUSTRALIA: Philip Beale, Kathryn Field, Peter Gibbs, Nick Pavlakis, Timothy Price; BELGIUM: Eric van Cutsem, Jochen Decaestecker, Alain Hendlisz, Yves Humblet, Marc Peeters,Jean-Luc Van Laethem; CANADA: Mary Mackenzie, Wilson Miller, Mark Rother, Rafal Wierzbicki,
Asif Shaik, Scott Berry; CHINA: Jianming Xu; CZECH REPUBLIC: Vladimira Stahalova, Ilona Kocakova, Bohuslav Melichar, Eugen Kubala; FRANCE: Marc Ychou, Olivier Bouche, Thierry Andre, Antoine Adenis,
Mohamed Hebbar, Olivier Dupuis, Jean-Francois Seitz, Laurent Mineur, Christian Borel; GERMANY:H.-J. Schmoll, Martin Becker, Claudio Denzlinger, Volker Heinemann, Meinolf Karthaus, Claus-Henning Koehne, Nicolas Ziegenhagen, Hendrik Kroening, Wolfgang Schepp, Tanja Trarbach, Michael Clemens,
Gunnar Folprecht, Ulrich Hacker, Ralf-Dieter Hofheinz, Arndt Vogel; HUNGARY: Janos Szanto,Laszlo Thurzo; ISRAEL: Adi Shani, Eina Shaham-Shmueli, Alex Beny, Ayala Hubert, Sofia Man,
Baruch Brenner; ITALY: Alberto Sobrero, Giacomo Carteni, Gabriele Luppi, Alfredo Falcone,Salvatore Siena, Alberto Zaniboni, Carlo Barone, Fortunato Ciardiello, Corrado Boni; JAPAN: Hideo Baba,
Hiroyuki Uetake, Takashi Ura, Yasuhide Yamada, Kensei Yamaguchi, Kentarou Yamazaki, Takayuki Yoshino, Hideyuki Mishima; NETHERLANDS: A. J. Gelderblom, D. H. Verheul; SPAIN: Josep Tabernero,Rocio Garcia-Carbonero, Carles Pericay Pijaume, Cristina Gravalos, Manuel Benavides, Javier Sastre,
Jaime Feliu, Mercedes Martinez Villaca; SWITZERLAND: Arnaud Roth; TURKEY: Mustafa Benekli,Faruk Aykan; USA: Axel Grothey, Billy Clowney, Martin Hyzinski, Ali Khojasteh, Marc Saltzman,
Heinz-Josef Lenz, Udit Verma, John Kugler, Jyotsna Fuloria, Kenneth Nahum, George Kim, Rex Mowat, Philip Stella, Martin Wiesenfeld, Brian Dicarlo, George Geils, Youram Nassir
The CORRECT trial was sponsored by Bayer HealthCare AG, Leverkusen, Germany