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AMGEN® LUMAKRAS ™ ( Sotorasib ) Combined With Vectibix® ( Panitumumab ) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C - Mutated Colorectal Cancer September 16 , 2021 New Data at ESMO 2021 Support Initiation of Phase 3 Trial of LUMAKRAS Plus Vectibix in Patients With 3L + Colorectal Cancer Amgen is Leading the Largest and Most Comprehensive Development Program in Patients with the KRAS G12C Mutation THOUSAND OAKS , Calif . , Sept. 16 , 2021 / PRNewswire / -- Amgen ( NASDAQ : AMGN ) today announced the first combination study results from the Phase 1b / 2 CodeBreak 101 study , the most comprehensive global clinical development program in patients with KRAS G12C - mutated advanced colorectal cancer ( CRC ) . These new data show that combining LUMAKRASTM ( sotorasib ) with Vectibi ( panitumumab ) , Amgen's monoclonal antibody epidermal growth factor receptor ( EGFR ) inhibitor , demonstrated encouraging efficacy and safety . Overall , the objective response rate ( ORR ) was 27 % ( confirmed and unconfirmed ) among 26 patients in the efficacy analysis set ( which included 5 patients who had progressed with prior sotorasib monotherapy ) . The disease control rate ( DCR ) was 81 % . ORR and DCR were secondary endpoints . In the expansion cohort of sotorasib - naïve patients with refractory CRC ( n = 18 ) , 33 % of patients experienced a response ( confirmed and unconfirmed ) . These data are being featured during the European Society of Medical Oncology 2021 ( ESMO21 ) Virtual Congress . " We are excited by these CodeBreak 101 data , which show encouraging response rates that were much higher than the 9.7 % response rate observed with LUMAKRAS monotherapy and highlight the importance of combination therapy for patients with KRAS G12C - mutated advanced colorectal cancer , " said David M. Reese , M.D. , executive vice president of Research and Development at Amgen . " Based on these results and the urgent need for new therapies , we are pleased to announce the initiation of a new Phase 3 trial with LUMAKRAS plus Vectibix in the third - line setting . This new trial , along with our doublet and triplet combination trials in colorectal cancer , demonstrates our commitment to delivering a new treatment option for metastatic CRC patients who harbor the KRAS G12C mutation . " In total , 31 patients with heavily pretreated ( median of two prior lines of therapy ; range 1-10 ) KRAS G12C - mutated metastatic CRC were enrolled in the dose exploration and dose expansion cohorts for the combination of LUMAKRAS and Vectibix . No patients experienced dose - limiting toxicities during the 28 days following initial treatment . The majority of treatment - related adverse events ( TRAES ) were Grade 1-2 in severity , and no Grade 4 or fatal TRAES were observed . The most common TRAES ( occurring in > 10 % of patients ) were consistent with known adverse events for LUMAKRAS and Vectibix and included dermatitis acneiform , dry skin , nausea , diarrhea , hypokalemia , hypomagnesemia , pruritus and rash . No new safety concerns were identified . " With treatment response rates being as low as 2 % in patients with colorectal cancer who progress in advanced stages , developing new treatment approaches for these patients is of critical interest , " said Marwan G. Fakih , M.D. , primary study investigator and co - director of the Gastrointestinal Cancer Program , City of Hope , Duarte , Calif . " Preclinical research has indicated that the addition of an EGFR inhibitor to KRASG12C inhibition can be synergistic , and now we have the first clinical data indicating the combination of sotorasib and panitumumab has the potential to be a safe and effective treatment for patients with KRAS G12C - mutated advanced CRC . " Advancing Tarlatamab ( formerly AMG 757 ) and AMG 404 in Small Cell Lung Cancer In addition to the LUMAKRAS combination research , a presentation will detail the design of an ongoing study of half - life extended ( HLE ) bispecific T cell engager ( BITE® ) molecule tarlatamab with anti - PD - 1 antibody AMG 404 in patients with small cell lung cancer . The multicenter , open - label , Phase 1b study will evaluate the safety and tolerability of the combination and determine dosing as primary objectives , as well as examine preliminary antitumor activity and pharmacokinetics as secondary objectives . Amgen to Webcast Investor Call at ESMO 2021 Amgen will host a webcast call for the investment community in conjunction with the European Society for Medical Oncology ( ESMO ) 2021 Congress . On Thursday , Sept. 16 , 2021 , at 8:30 a.m. ET , David M. Reese , M.D. , executive vice president of Research and Development at Amgen , along with other members of Amgen's management team , will discuss clinical data being presented on the Company's KRASG12C inhibitor LUMAKRAST ( sotorasib ) in combination with VectibixⓇ ( panitumumab ) . Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media , investors and the general public . The webcast , as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences , can be accessed on Amgen's website , www.amgen.com , under Investors . Information regarding presentation times , webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar . The webcast will be archived and available for replay for at least 90 days after the event . About LUMAKRASTM ( sotorasib ) Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS , a KRASG12C inhibitor.1 LUMAKRAS has demonstrated a positive benefit - risk profile with rapid , deep and durable anticancer activity in patients with locally advanced or metastatic non - small cell lung cancer ( NSCLC ) harboring the KRAS G12C mutation with a once daily oral formulation.2 In May 2021 , LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S. , under accelerated approval . LUMAKRAS is also approved in the United Arab Emirates , and in Great Britain and Canada under Project Orbis . Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens , including triplets , with clinical trial sites spanning five continents . To date , LUMAKRAS has treated almost 3,000 patients around the world through the clinical development program and commercial use .