{"id":535836,"date":"2021-09-08T16:03:28","date_gmt":"2021-09-08T20:03:28","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/amgen-presents-new-data-from-thoracic-oncology-portfolio-at-wclc21\/"},"modified":"2021-09-08T16:03:28","modified_gmt":"2021-09-08T20:03:28","slug":"amgen-presents-new-data-from-thoracic-oncology-portfolio-at-wclc21","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/amgen-presents-new-data-from-thoracic-oncology-portfolio-at-wclc21\/","title":{"rendered":"Amgen Presents New Data From Thoracic Oncology Portfolio At WCLC21"},"content":{"rendered":"
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New LUMAKRAS\u2122 (sotorasib) Post-Hoc Analysis Shows Intracranial Disease Control was Achieved in a Subset of Patients With Previously Treated Evaluable Stable Brain Metastases<\/h2>\n

Additional Featured Research Includes Exploratory Analysis of Potential Genomic Determinants of LUMAKRAS Response<\/h2>\n

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

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\n THOUSAND OAKS, Calif.<\/span>, Sept. 8, 2021<\/span> \/PRNewswire\/ —\u00a0Amgen (NASDAQ: AMGN) today announced results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS\u2122 (sotorasib), the first and only KRASG12C<\/sup>\u00a0inhibitor approved in the U.S., in the treatment of previously treated patients with advanced or metastatic KRAS<\/i> G12C-mutated non-small cell lung cancer (NSCLC). These new analyses, respectively, provide encouraging evidence of durable systemic anticancer activity in patients with previously treated, stable brain metastases with LUMAKRAS, as well as insights into biomarkers of LUMAKRAS response. Together with a poster describing a recently initiated clinical study of the investigational half-life extended (HLE) bispecific T cell engager (BiTE\u00ae<\/sup>) molecule acapatamab (formerly AMG 160) in patients with NSCLC, these data are being featured during the virtual 2021 World Conference on Lung Cancer (WCLC21) hosted by the International Association for the Study of Lung Cancer (IASLC). <\/p>\n

“Amgen is expanding the reach, impact and potential of our innovative therapies to personalize care for patients with historically difficult-to-treat cancers like lung cancer,” said David M. Reese<\/span>, M.D., executive vice president of Research and Development at Amgen. “We are pleased to present additional analyses for LUMAKRAS, our newly approved KRASG12C<\/sup> inhibitor, as well as a trial-in-progress poster for acapatamab, our investigational BiTE molecule being studied in NSCLC and other solid tumors. Of the data presented at WCLC, we are particularly encouraged by the first evaluation of LUMAKRAS’ ability to maintain stabilization of brain metastases in patients with previously treated, stable brain metastases. We look forward to the results from our CodeBreaK 101 study where we are studying a cohort of KRAS <\/i>G12C-mutated NSCLC patients with untreated, active brain metastases to better understand the clinical benefit of LUMAKRAS.”<\/p>\n

\n New Analyses From the LUMAKRAS Phase 2 CodeBreaK 100 Clinical Trial
<\/b>In a post-hoc analysis (WCLC21 Poster 52.03) of 40 patients (23% of 174 trial participants) with KRAS<\/i> G12C-mutated advanced NSCLC who had stable, previously treated brain metastases at their enrollment in the CodeBreaK 100 trial, LUMAKRAS achieved a 77.5% disease control rate (DCR), a median progression-free survival (PFS) of 5.3 months and a median overall survival (OS) of 8.3 months. This DCR was similar to patients without brain metastases. In patients evaluable by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria, 14 of 16 patients (88%) maintained intracranial disease control of their stable brain lesions during LUMAKRAS therapy with two achieving complete responses of non-target lesions. The safety profile of LUMAKRAS in the brain metastases group was consistent with previous reports. Amgen is enrolling patients with active brain metastases in an arm of the CodeBreaK 101 study (NCT04185883<\/a>).<\/p>\n

“Up to 40% of patients with\u00a0KRAS<\/i>\u00a0G12C-mutated NSCLC may develop brain metastases.1<\/sup>\u00a0Given the overall poor prognosis for this patient subset, there is an urgent need for novel treatment options,”2 <\/sup>said lead author Suresh S. Ramalingam<\/span>, M.D., executive director of Winship Cancer Institute of Emory University<\/span> in Atlanta<\/span>. “Our results demonstrate the potential of sotorasib to provide meaningful clinical benefit for\u00a0KRAS<\/i>\u00a0G12C-mutated NSCLC in the brain.”<\/p>\n

An additional exploratory descriptive analysis of CodeBreaK 100 being presented during a Mini Oral Presentation (MA14.03) examined whether the mutation profile of the tumors, in addition to KRASG12C<\/sup>, is correlated with patients’ responses or resistance to LUMAKRAS. An analysis of baseline tumor samples from 65 patients revealed no single genetic signature that predicted LUMAKRAS responses and ongoing evaluations will be needed to further identify potential targetable mechanisms of resistance. However, the KEAP1<\/i> mutation, a known driver of poor clinical outcomes, was observed in 7 of 22 patients with early progression and PFS of less than 3 months. <\/p>\n

“The introduction of sotorasib ushered in a new standard of care for patients with KRAS<\/i> G12C-mutated NSCLC,” said lead author Ferdinandos Skoulidis, M.D., Ph.D., assistant professor of Thoracic\/Head and Neck Medical Oncology at\u00a0The University of Texas<\/span> MD Anderson Cancer Center. “These biomarker data provide direction for continued research into characterizing mutation profiles associated with sotorasib treatment response to help guide clinical practice and inform innovative combination approaches to overcome potential mechanisms of resistance.”<\/p>\n

\n Advancing BiTE Molecule Acapatamab in NSCLC
<\/b>In addition to the LUMAKRAS data, a trial-in-progress abstract outlined the design of an ongoing open-label, Phase 1b<\/span> study (NCT04822298<\/a>) evaluating the safety and tolerability of acapatamab, a half-life extended BiTE immuno-oncology therapy that targets prostate specific membrane antigen (PSMA)-expressing cancer cells in adults with relapsed\/refractory NSCLC. The encouraging benefit-risk profile of acapatamab in an ongoing trial of patients with metastatic castration-resistant prostate cancer (mCRPC) (NCT03792841<\/a>) suggested its potential for patients with NSCLC, as up to 49 to 85% of the endothelial cells in a tumor’s newly grown blood supply express PSMA.3,4<\/sup> Acapatamab engages PSMA on cancer cells and CD3 on T cells, inducing T-cell activation, proliferation and target cell lysis to prompt a cancer-fighting immune response.5<\/sup>\u00a0\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.6<\/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.7<\/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>.<\/p>\n

Amgen is progressing the largest and broadest global KRASG12C<\/sup> 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 submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia<\/span>, Brazil<\/span>, Canada<\/span> and the United Kingdom<\/span>. Additionally, Amgen has submitted an MAA in the EU and New Drug Applications in Japan<\/span> (J-NDA), Switzerland<\/span>, South Korea<\/span>, Singapore<\/span>, Israel<\/span>, Turkey<\/span> and Taiwan<\/span>.<\/p>\n

LUMAKRAS is also being studied in multiple other solid tumors.6<\/sup><\/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