{"id":538950,"date":"2021-09-16T04:33:12","date_gmt":"2021-09-16T08:33:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lumakras-sotorasib-combined-with-vectibix-panitumumab-showed-encouraging-efficacy-and-safety-in-patients-with-kras-g12c-mutated-colorectal-cancer\/"},"modified":"2021-09-16T04:33:12","modified_gmt":"2021-09-16T08:33:12","slug":"lumakras-sotorasib-combined-with-vectibix-panitumumab-showed-encouraging-efficacy-and-safety-in-patients-with-kras-g12c-mutated-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lumakras-sotorasib-combined-with-vectibix-panitumumab-showed-encouraging-efficacy-and-safety-in-patients-with-kras-g12c-mutated-colorectal-cancer\/","title":{"rendered":"LUMAKRAS\u2122 (Sotorasib) Combined With Vectibix\u00ae (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer"},"content":{"rendered":"
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New Data at ESMO 2021 Support Initiation of Phase 3 Trial of LUMAKRAS Plus Vectibix in Patients With 3L+ Colorectal Cancer<\/h2>\n

Amgen is Leading the Largest and Most Comprehensive Development Program in Patients with the KRAS G12C Mutation<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n THOUSAND OAKS, Calif.<\/span>, Sept. 16, 2021<\/span> \/PRNewswire\/ — Amgen (NASDAQ: AMGN) today announced the first combination study results from the Phase 1b<\/span>\/2 CodeBreaK 101 study, the most comprehensive global clinical development program in patients with KRAS<\/i> G12C-mutated advanced colorectal cancer (CRC). These new data show that combining LUMAKRAS\u2122 (sotorasib) with Vectibix\u00ae<\/sup> (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-na\u00efve 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. <\/p>\n

“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<\/i> G12C-mutated advanced colorectal cancer,” said David M. Reese<\/span>, 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<\/i> G12C mutation.”<\/p>\n

In total, 31 patients with heavily pretreated (median of two prior lines of therapy; range 1-10) KRAS<\/i> 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.<\/p>\n

“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<\/span>, M.D., primary study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif.<\/span> “Preclinical research has indicated that the addition of an EGFR inhibitor to KRASG12C<\/sup> 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<\/i> G12C-mutated advanced CRC.”<\/p>\n

\n Advancing Tarlatamab (formerly AMG 757) and AMG 404 in Small Cell Lung Cancer
<\/b>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\u00ae<\/sup>)\u00a0molecule tarlatamab with anti-PD-1 antibody AMG 404 in patients with small cell lung cancer. The multicenter, open-label, Phase 1b<\/span> 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. <\/p>\n

\n Amgen to Webcast Investor Call at ESMO 2021
<\/b>Amgen will host a webcast call for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2021 Congress. On\u00a0Thursday, Sept. 16, 2021, at\u00a08:30 a.m. ET,\u00a0 David M. Reese<\/span>, M.D., executive vice president of Research and Development at\u00a0Amgen, along with other members of\u00a0Amgen’s management team, will discuss clinical data being presented on the Company’s KRASG12C<\/sup> inhibitor LUMAKRAS\u2122 (sotorasib) in combination with Vectibix\u00ae<\/sup> (panitumumab).<\/p>\n

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.\u00a0 <\/p>\n

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<\/a>, 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.\u00a0 \u00a0<\/p>\n

\n About LUMAKRASTM<\/sup> (sotorasib)
<\/b>Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRASG12C<\/sup>\u00a0inhibitor.1<\/sup> 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 <\/i>G12C\u00a0mutation with a once daily oral formulation.2<\/sup><\/p>\n

In May 2021<\/span>, LUMAKRAS was the first KRASG12C<\/sup> 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<\/span>, and in Great Britain<\/span> and Canada<\/span> under Project Orbis.<\/p>\n

Amgen is progressing the largest and broadest global KRASG12C<\/sup> 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. <\/p>\n

In the U.S., LUMAKRAS was reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen is participating in the FDA’s Project Orbis initiative and through the initiative, has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia<\/span> and Brazil<\/span>. Additionally, Amgen has submitted an MAA in the European Union, Japan<\/span>, Switzerland<\/span>, South Korea<\/span>, Singapore<\/span>, Israel<\/span>, Turkey<\/span>, Taiwan<\/span>, Colombia<\/span>, Thailand<\/span>, Mexico<\/span> and Hong Kong<\/span>.<\/p>\n

LUMAKRAS is also being studied in multiple other solid tumors.1<\/sup><\/p>\n

\n About CodeBreaK
<\/b>The CodeBreaK clinical development program for\u00a0Amgen’s drug sotorasib is designed to treat patients with an advanced solid tumor with the\u00a0KRAS <\/i>G12C\u00a0mutation and address the longstanding unmet medical need for these cancers. As the most advanced\u00a0KRASG12C<\/sup> inhibitor clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumor types since its inception.<\/p>\n

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with\u00a0KRAS <\/i>G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been submitted for publication.\u00a0 <\/p>\n

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS <\/i>G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b<\/span> studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS<\/i> G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201). <\/p>\n

For information, please visit www.hcp.codebreaktrials.com<\/a>. <\/p>\n

\n About Advanced Colorectal Cancer and the KRAS <\/i>G12C Mutation
<\/b>Colorectal cancer (CRC) is the second leading cause of cancer deaths worldwide, comprising 10% of all cancer diagnoses.3<\/sup> It is also the third most commonly diagnosed cancer globally.4<\/sup><\/p>\n

Patients with previously treated metastatic CRC need more effective treatment options, as standard therapies yield median PFS times of about two months and patients’ response rates are less than 2%. 5,6 <\/sup><\/p>\n

KRAS mutations are among the most common genetic alterations in colorectal cancers, with the KRAS<\/i> G12C mutation present in approximately 3-5% of colorectal cancers.7,8,9<\/sup><\/p>\n

\n About BiTE\u00ae<\/sup> Technology
<\/b>BiTE\u00ae<\/sup> (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage a patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing BiTE molecules across a broad range of hematologic malignancies and solid tumors and further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.<\/p>\n

\n LUMAKRASTM<\/sup> (sotorasib) U.S. Indication
<\/b>LUMAKRASTM<\/sup> is indicated for the treatment of adult patients with KRAS <\/i>G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.<\/p>\n

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).<\/p>\n

\n LUMAKRAS\u2122 (sotorasib) Important Safety Information<\/b>\n <\/p>\n

\n Hepatotoxicity<\/b>\n <\/p>\n