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- |||| sotorasib (AMG 510) / Amgen
Clinical: In fact, we had good experience with AMG510 in 2 KRAS G12C mut. #mcrc patients as pointed out by @BenWestphalen. Data at #ASCO20 were promising for phase I, with good efficacy for later line treatment and moderate toxicity. (Twitter) - Jun 22, 2020
- ||||| sotorasib (AMG 510) / Amgen
Clinical, IO Biomarker: 3/3 muy FB posts. ... or targeted to mutations. So some researchers might be thinking of a clinical trial (e.g. AMG-510 trial for a certain kind of KRAS mutation or the immunotherapy plus BRAF inhibitors trials.) So please consult your oncologist for their medical opinion. (Twitter) - Jun 16, 2020
- |||||| Lumakras (sotorasib) / Amgen
Enrollment open, Metastases: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). (clinicaltrials.gov) - Jun 15, 2020
P3, N=650, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting
- || Lumakras (sotorasib) / Amgen
Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (clinicaltrials.gov) - Jun 11, 2020
P1/2, N=533, Recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial primary completion date: Dec 2023 --> Jan 2022
- |||| sotorasib (AMG 510) / Amgen
Clinical: In a cohort of 25 patients treated with AMG 510 confirmed partial responses were observed in 3 patients who had appendiceal cancer, melanoma, & endometrial cancer, respectively; 13 patients achieved stable disease. @DavidHongMD @MDAndersonNews #ASCO20 https://t.co/2FLXz22CBt (Twitter) - Jun 8, 2020
- | sotorasib (AMG 510) / Amgen
【学会速報】CodeBreak 100試験：KRAS G12C変異型大腸がんに対するAMG510の有効性 #ASCO20 https://t.co/tG2ejeFkoJ (Twitter) - Jun 5, 2020
- || Lumakras (sotorasib) / Amgen
Trial primary completion date, Monotherapy, PD(L)-1 Biomarker, IO biomarker: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - Jun 4, 2020
P1b, N=430, Recruiting, Sponsor: Amgen
Trial primary completion date: Dec 2023 --> Jan 2022 Trial primary completion date: Jun 2022 --> Feb 2026
- ||||| sotorasib (AMG 510) / Amgen
Clinical: AMG 510, a novel KRAS G12C inhibitor, demonstrated early evidence of a consistent safety profile and anticancer activity across a range of advanced KRAS G12C-mutant solid tumors other than NSCLC and CRC. @DavidHongMD @MDAndersonNews @ASCO #ASCO20 https://t.co/KeMHvfsJ91 (Twitter) - Jun 1, 2020
- |||||| sotorasib (AMG 510) / Amgen
Clinical: We have the site intiation visit in a few days. Already have 6 patients with 🧬KRAS-G12C for the combination approaches. AMG-510➕ MEK⛔️ Or #Immunotherapy approaches. Recent data regarding EGFR⛔️ similar to 💡lessons @skopetz @agrothey on BEACON BRAFV600E #CRCSM. #ASCO20 @NEJM. (Twitter) - May 30, 2020
- ||||| sotorasib (AMG 510) / Amgen
Clinical: AMG 510 Shows Clinical Activity in Advanced KRAS G12C-Mutant Solid Tumors @DavidHongMD @MDAndersonNews @ASCO #ASCO20 https://t.co/AvA355GKLJ (Twitter) - May 30, 2020
- ||| sotorasib (AMG 510) / Amgen
Results coming out of the CodeBreak100 trial of the KRAS G12C inhibitor AMG 510 (now sotorasib!) presented at #ASCO20 (abstract #4018 @mgfakih @DavidHongMD) suggest that responses in mCRC < other tumor types like NSCLC (1/4) (Twitter) - May 30, 2020
- || sotorasib (AMG 510) / Amgen
This is AMG510 from @Amgen (Twitter) - May 29, 2020
- ||| sotorasib (AMG 510) / Amgen
And I thought that sitting in last year's #ASCO lung plenary while simultaneously watching on my phone @DavidHongMD present the #AMG510 #KRAS inhibitor data in a separate session was insane. Virtual #ASCO20 is a whole new level. Another first - watching myself give a talk :) (Twitter) - May 29, 2020
- |||| sotorasib (AMG 510) / Amgen
Clinical: CodeBreak 100 (Abs 3511) Responses to AMG510 across tumor types in patients with KRAS G12C mutations @DavidHongMD #ASCO20 (Twitter) - May 29, 2020
- || sotorasib (AMG 510) / Amgen
Looking forward to watching these Poster Talks with Dr. Fakih Trial in progress: A phase Ib study of AMG 510, https://t.co/SXvlKRFQI3 CodeBreak 100 https://t.co/Gw4D4udY9P @mgfakih @cityofhope (Twitter) - May 29, 2020
- |||| sotorasib (AMG 510) / Amgen
Clinical: Proud to present CODEBREAK100 (abstract 4018): AMG510 in KRASG12C mCRC #ASCO2020. PFS = 4.2 m & DCR 80% at 960 mg QD in a refractory population. now moving to combinations on CODEBREAK101 (TPS3661). More options for our pts! @AmgenOncology @cityofhope @FightCRC @TheColonClub (Twitter) - May 24, 2020
- || Lumakras (sotorasib) / Amgen
Enrollment change, Trial completion date, Monotherapy, PD(L)-1 Biomarker, IO biomarker: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - May 21, 2020
P1b, N=430, Recruiting, Sponsor: Amgen
Trial primary completion date: Jun 2022 --> Feb 2026 N=250 --> 430 | Trial completion date: Jul 2024 --> Feb 2026
- || sotorasib (AMG 510) / Amgen
We also just re-opened AMG510 multi arm study @UCD_Cancer thanks to @drgandara! (Twitter) - May 20, 2020
- MRTX849 / Mirati, sotorasib (AMG 510) / Amgen
Molecular profile of KRAS G12C-mutant non-small-cell lung cancer and colorectal cancer in Brazilian patients (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3681;
A relatively high number of patients may present with KRAS G12C-mutant cancers in Brazil, indicating the relevance of identifying such cases for targeted therapy. Further studies will deepen the analysis of clonality and heterogeneity in this cohort.
- MRTX849 / Mirati, sotorasib (AMG 510) / Amgen
Positioning a selective, bi-steric inhibitor of mTORC1 as a combination partner in RAS-driven cancers (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2446;
The mechanistic bases for these combinatorial effects are currently under investigation. Our preclinical results reinforce the importance of mTORC1 as a concurrent target in genetically defined RAS-mutant cancers, and showcase the therapeutic potential of a novel and selective bi-steric mTORC1 inhibitor, currently in IND-enabling studies.
- IN10018 / InxMed
Focal adhesive kinase inhibitor IN10018 sensitizes KRAS mutant cancer and overcomes drug resistance of KRAS G12C inhibition (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1640;
IN10018 significantly decreased the upregulated FAK Y397 phosphorylation in the combination treatments, underlying the mechanism of synergy between the two inhibitors. Our results indicate that KRAS G12C cancer patients can be better treated by the combination of IN10018 with KRAS G12C inhibitor.
- Opdivo (nivolumab) / Ono Pharma, BMS
Actionable genomic landscape of metastatic colorectal cancer patients in Korea: Interim data from K-MASTER project (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1615;
There are 2 clinical trials which mCRC patients can participate in early 2020; MET alteration in KM-08 (Tepotinib), high tumor mutation burden in KM-12 (Ipilimumab and nivolumab).In conclusion, this project is efficient to detect actionable variations in mCRC...By help of regulatory approval of innovative drugs and off-label use, biomarker-driven early phase clinical trials, it could be a huge therapeutic opportunity for refractory mCRC patients. (This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health &Welfare, Republic of Korea (Grant number: HI17C2206).
- repotrectinib (TPX-0005) / Turning Point Therapeutics, FAK-JAK 2 dual Inhib / Teva
Repotrectinib increases effectiveness of KRAS-G12C inhibitors in KRAS-G12C mutant cancer models via simultaneous SRC/FAK/JAK2 inhibition (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1306;
Additional combination data in KRAS-G12C mutant cancer models will be presented. Overall, these studies warrant further clinical investigation on the combination of KRAS-G12C inhibitors with repotrectinib in patients with KRAS-G12C mutation for potential response and duration improvement of current investigational KRAS-G12C inhibitors.
- SHP2 inhibition as the backbone of targeted therapy combinations for the treatment of cancers driven by oncogenic mutations in the RAS pathway (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1297;
However, the corresponding combinations markedly increased the number and depth of tumor regressions. Translation of these preclinical findings into clinical benefit could position RMC-4630, an investigational therapeutic agent, as a backbone of targeted therapy combinations for patients bearing cancers with diverse oncogenic mutations in the RAS pathway.
- || Lumakras (sotorasib) / Amgen
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (clinicaltrials.gov) - May 14, 2020
P1/2, N=533, Recruiting, Sponsor: Amgen
Translation of these preclinical findings into clinical benefit could position RMC-4630, an investigational therapeutic agent, as a backbone of targeted therapy combinations for patients bearing cancers with diverse oncogenic mutations in the RAS pathway. Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
- || Lumakras (sotorasib) / Amgen
New P1 trial, Metastases: AMG 510 Ethnic Sensitivity Study (CodeBreaK 105). (clinicaltrials.gov) - May 7, 2020
P1, N=12, Recruiting, Sponsor: Amgen
- sotorasib (AMG 510) / Amgen
[VIRTUAL] AMG 510, a novel small molecule inhibitor of KRAS G12C, for patients with advanced gastrointestinal cancers: Results from the CodeBreak 100 phase 1 trial () - May 3, 2020 - Abstract #ESMOGI2020ESMO_GI_96;
P1/2
(clinical trial information: NCT03600883) Legal entity responsible for the study Amgen Inc. Funding Amgen Inc.
- sotorasib (AMG 510) / Amgen
[VIRTUAL] Landscape of RAS variations in 17993 solid tumors: a pan-cancer analysis. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_3763;
These patients may benefit from KRAS inhibitors. Research Funding: None
- sotorasib (AMG 510) / Amgen
[VIRTUAL] Trial in progress: A phase Ib study of AMG 510, a specific and irreversible KRASG12C inhibitor, in combination with other anticancer therapies in patients with advanced solid tumors harboring KRAS p.G12C mutation (CodeBreak 101). (Poster Board 391) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1608;
P1b
For more information, please contact Amgen Medical Information: medinfo@amgen.com. Research Funding: Amgen Inc.
- sotorasib (AMG 510) / Amgen
[VIRTUAL] CodeBreak 100: Phase I study of AMG 510, a novel KRASG12C inhibitor, in patients (pts) with advanced solid tumors other than non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). (Poster Board 241) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1461;
P1/2
AMG 510 was well tolerated and demonstrated clinical activity in pts with advanced KRAS p.G12C mutant solid tumors other than NSCLC and CRC. Research Funding: Amgen Inc.
- |||| sotorasib (AMG 510) / Amgen
Clinical, Next-Generation Sequencing, Heterogeneity: copied from above: 2 TKI-naïve pts had negative mt screening by FISH (ALK) & cfDNA (EGFR), found via NGS on resected tumor, speaks to tumor heterogeneity and pitfalls of FNA sampling and blood-based NGS platforms. Also, for KRAS G12c, AMG 510 was still a stranger at enrollment (Twitter) - Apr 28, 2020
- |||| sotorasib (AMG 510) / Amgen
Clinical, Tumor-specific neoantigens, Next-Generation Sequencing: Caveats, 2 pts had negative screening (ALK FISH & ctDNA EGFR), found via NGS on TIL resection, AMG 510 didn't "exist" @ enrollment (G12c), and neoantigen # less important if enriching for T cells w/ high affinity for predicted autologous tumor neoepitopes (quality >> quantity) 🤯 (Twitter) - Apr 28, 2020
- ||| MRTX849 / Mirati, VS-6766 / Verastem, sotorasib (AMG 510) / Amgen
Clinical: $VSTM was a bit hype upto #AACR20 data readout (SP ws 2x in a mo) For KRASG12V $VSTM: VS-6766 showed 1/10 pts PR + Resale of Up To 46.5 M shares of Comm stock Now, comparatively For KRASG12C $AMGN: AMG 510 @ASCO19 - 5/10 pts showed PR $MRTX: MRTX849 @AACR19 – 3/5 pts showed PR (Twitter) - Apr 27, 2020
- ||||| sotorasib (AMG 510) / Amgen
Clinical: #AACR20 Important to know the spectrum of #KRAS and now the specific codons. #Clinicaltrials 🆕 for the #KRASG12C #AMG510 and other 💊. #CRCSM #PANCSM #LCSM #PrecisionMedicine Importance of co-occurring mutations. Interesting co-mutation patterns & dependencies. Type-specific🧬. (Twitter) - Apr 27, 2020
- |||| Lumakras (sotorasib) / Amgen
Trial primary completion date, Metastases: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). (clinicaltrials.gov) - Apr 23, 2020
P3, N=650, Not yet recruiting, Sponsor: Amgen
Research Funding: Amgen Inc. Trial primary completion date: Jul 2021 --> Oct 2021
- || sotorasib (AMG 510) / Amgen
Clinical, Journal: The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. (Pubmed Central) - Apr 14, 2020
Cured mice rejected the growth of isogenic KRAS tumours, which suggests adaptive immunity against shared antigens. Furthermore, in clinical trials, AMG 510 demonstrated anti-tumour activity in the first dosing cohorts and represents a potentially transformative therapy for patients for whom effective treatments are lacking.
- ||| Lumakras (sotorasib) / Amgen
Enrollment change, Combination therapy, Monotherapy, Metastases: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (clinicaltrials.gov) - Apr 8, 2020
P1/2, N=533, Recruiting, Sponsor: Amgen
Furthermore, in clinical trials, AMG 510 demonstrated anti-tumour activity in the first dosing cohorts and represents a potentially transformative therapy for patients for whom effective treatments are lacking. N=350 --> 533
- || Lumakras (sotorasib) / Amgen
Enrollment change, Trial completion date, Trial primary completion date, Monotherapy, PD(L)-1 Biomarker, IO biomarker: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - Mar 24, 2020
P1b, N=250, Recruiting, Sponsor: Amgen
N=350 --> 533 N=120 --> 250 | Trial completion date: Jan 2025 --> Jul 2024 | Trial primary completion date: Sep 2022 --> Apr 2022
- ||| sotorasib (AMG 510) / Amgen
Clinical: Good morning, the Oncopole in Toulouse will do it for patients to avoid risks. Of course only when it’s possible. But for patients AMG510 with oral médication it’s a good thing! (Twitter) - Mar 18, 2020
- |||||||||| Lumakras (sotorasib) / Amgen
New P3 trial, Metastases: Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). (clinicaltrials.gov) - Mar 11, 2020
P3, N=650, Not yet recruiting, Sponsor: Amgen
- || AMG 510 / Amgen
Great review! Looking forward to proof of concept. Already have trials exploring some these mechanisms with the AMG510 (Twitter) - Mar 4, 2020
- || AMG 510 / Amgen
Reviewed this insightful mechanistic work from your colleagues on a resistance mechanism in light of the pre-clinical combinations of chemo-, immuno-, and targeted-therapies with AMG-510 (https://t.co/aBmRbYq0Du) at a recent journal club @hopkinskimmel. 1/2 (Twitter) - Mar 3, 2020
- sotorasib (AMG 510) / Amgen
[VIRTUAL] Prognostic differences of RAS mutations: Results from South Australian (SA) metastatic colorectal (mCRC) registry. (Poster Board 59) - Feb 27, 2020 - Abstract #ASCO2020ASCO_320;
Whilst the G12S mutation was associated with the longest survival numerically, the observed survival for patients with the most common RAS mutations (G12C, G12V, G12A, G12D and G13D) did not significantly differ. Research Funding: None
- sotorasib (AMG 510) / Amgen
[VIRTUAL] CodeBreak 100: Activity of AMG 510, a novel small molecule inhibitor of KRASG12C, in patients with advanced colorectal cancer. (Poster Board 10) - Feb 27, 2020 - Abstract #ASCO2020ASCO_270;
P1/2
Study is ongoing. Research Funding: Amgen Inc.
- || Review, Journal, IO Biomarker: KRAS G12C Game of Thrones, which direct KRAS inhibitor will claim the iron throne? (Pubmed Central) - Feb 26, 2020
Given the rapid clinical development of 4 direct covalent KRAS G12C inhibitors within a short period of time, understanding the similarities and differences among these will be important to determine the best treatment option based on tumor specific response (NSCLC versus colorectal carcinoma), potential resistance mechanisms (i.e. anticipated acquired mutation at the cysteine 12 residue) and central nervous system (CNS) activity. Additionally, further investigation evaluating the efficacy and safety of combination therapies with agents such as immune checkpoint inhibitors will be important next steps.
- AMG 510 / Amgen
AMG 510 (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_140;
- || Lumakras (sotorasib) / Amgen
Trial completion date, Combination therapy, Monotherapy, Metastases: A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) (clinicaltrials.gov) - Feb 17, 2020
P1/2, N=350, Recruiting, Sponsor: Amgen
Additionally, further investigation evaluating the efficacy and safety of combination therapies with agents such as immune checkpoint inhibitors will be important next steps. Trial completion date: Mar 2024 --> Aug 2023
- ||||| AMG 510 / Amgen
The next few years are bright for new selective KRAS inhibitors for nsclc. A lot of activity in this space nicely outlined by @DavidHongMD at #CLCCO. AMG510 do we have the right dose? Will it have CNS activity? (Twitter) - Feb 7, 2020
- ||| AMG 510 / Amgen
Guardant Health and Amgen to Develop CDx Test for AMG 510 in KRAS G12C+ NSCLC https://t.co/HAJgEfFIj4 @TargetedOnc 님이 공유 (Twitter) - Jan 31, 2020
- | AMG 510 / Amgen
Journal, IO Biomarker: Mutant KRAS at the Heart of Tumor Immune Evasion. (Pubmed Central) - Jan 26, 2020
In Nature, Canon et al. (2019) describe how the novel KRAS-G12C inhibitor AMG 510 can potentiate immune rejection in combination with immune checkpoint blockade.