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- | Lumakras (sotorasib) / Amgen
Enrollment open, Metastases: SOLUCOM: Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities (clinicaltrials.gov) - Jun 2, 2022
P2, N=100, Recruiting, Sponsor: Vestre Viken Hospital Trust
Not yet recruiting --> Recruiting
- | Lumakras (sotorasib) / Amgen
New P2 trial: Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC (clinicaltrials.gov) - May 31, 2022
P2, N=25, Not yet recruiting, Sponsor: Fox Chase Cancer Center
- ||| Lumakras (sotorasib) / Amgen
Thanks for sharing this, Aakash! We all continue to learn more & more about sequencing. This data is very important in day to day management. “We suggest an excess of immune-mediated AE with sequential sotorasib following anti-PD(L)1” was shared by @MDuruisseaux (Twitter) - May 31, 2022
- ||| inlexisertib (DCC-3116) / Ono Pharma
Phase classification, Enrollment change, Combination therapy, Monotherapy, Metastases: A Phase 1/2 Study of DCC-3116 in Patients With RAS/MAPK Pathway Mutant Solid Tumors (clinicaltrials.gov) - May 30, 2022
P1/2, N=323, Recruiting, Sponsor: Deciphera Pharmaceuticals LLC
Not yet recruiting --> Recruiting Phase classification: P1 --> P1/2 | N=130 --> 323
- | Lumakras (sotorasib) / Amgen
New P2 trial: MERIT-lung: Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy (clinicaltrials.gov) - May 30, 2022
P2, N=43, Recruiting, Sponsor: Fundaci
- || Review, Journal, Heterogeneity, PD(L)-1 Biomarker: Colorectal Cancer Heterogeneity and the Impact on Precision Medicine and Therapy Efficacy. (Pubmed Central) - May 30, 2022
Trastuzumab and trastuzumab deruxtecan exhibited promising and durable activity in HER-2-positive patients...We highlight the differential effect of new targeted therapies through an ever-deeper characterization of tumor tissue. An overview of ongoing clinical trials is also provided.
- |||| Lumakras (sotorasib) / Amgen
You may find interesting this work presented at ELCC22. We suggest an excess of immune-mediated AE with sequential sotorasib following anti-PD(L)1, mostly hepatitis. Paper in preparation that will include sotorasib activity data. #LCSM @DrJNaidoo @OncBrothers @DrSanjayPopat (Twitter) - May 25, 2022
- ||||| Lumakras (sotorasib) / Amgen
FDA event, Reimbursement: Same here...me to pt Your cancer progressed but i've good news Your tumor has this mutation G12C and we have a great new drug: Lumakras Insurance: hold on, pt might think she has ins benefits and drug is FDA approved but request is still denied Me:the US ins system is LUDIKRAS! https://t.co/ErhBGvVxVx (Twitter) - May 25, 2022
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Review, Journal, IO biomarker: Limited role of KRAS mutation in guiding immunotherapy in advanced non-small-cell lung cancer. (Pubmed Central) - May 25, 2022
The role of KRAS in affecting the response to immunotherapy in non-small-cell lung cancer has not been fully elucidated. The purpose of this review was to summarize the impact of KRAS mutations, a highly heterogeneous group, on immunotherapy to provide clinicians and researchers with relevant information that can help guide decision-making.
- | Lumakras (sotorasib) / Amgen
Journal: Kicking KRAS to tackle lung cancer. (Pubmed Central) - May 24, 2022
KRAS is one of the most commonly mutated oncogenes in lung cancer but has long been considered undruggable. With the recent FDA approval of sotorasib, supported by positive phase II trial data now published in The New England Journal of Medicine, this is no longer the case.
- ||| Lumakras (sotorasib) / Amgen
With large tumor burden, would be inclined to stick with Chemo + IO and then sotorasib for 2L. (Twitter) - May 24, 2022
- ||||| adavosertib (AZD1775) / AstraZeneca, Lumakras (sotorasib) / Amgen, VIC-1911 / VITRAC Therap
When Drs. @BarbaraBurtness & Jong Woo Lee added the WEE1 inhibitor adavosertib to the AURKA inhibitor VIC-1911 & tested the combo against KRAS-mutated lung cancer cells w/ resistance to sotorasib, the result was extensive cell death. Learn more: https://t.co/lerN8zQH6h (Twitter) - May 24, 2022
- ||| Lumakras (sotorasib) / Amgen
Especially relevant now that we have sotorasib...I guess these data will help answer that q re: how we prioritize KRAS targeting agents vs IO. If you had a pt w KRAS G12C and PD-L1 TPS of 90%, which way would you go? #TumorBoardTuesday (Twitter) - May 24, 2022
- | Lumakras (sotorasib) / Amgen
Journal: Sotorasib: a KRAS inhibitor for non-small cell lung cancer. (Pubmed Central) - May 18, 2022
With the recent FDA approval of sotorasib, supported by positive phase II trial data now published in The New England Journal of Medicine, this is no longer the case. No abstract available
- | Preclinical, Journal, IO biomarker: Inhibitor of the Nuclear Transport Protein XPO1 Enhances the Anticancer Efficacy of KRAS G12C Inhibitors in Preclinical Models of KRAS G12C-Mutant Cancers. (Pubmed Central) - May 17, 2022
FDA has recently granted approval to sotorasib for KRAS G12C mutated non-small cell lung cancer (NSCLC)...In this study, combining nuclear transport inhibitor selinexor with KRAS G12C inhibitors has resulted in potent antitumor effects in preclinical cancer models. This can be an effective combination therapy for cancer patients that do not respond or develop resistance to KRAS G12C inhibitor treatment.
- ||||| adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Clinical: I was happy to present an update on adagrasib (MRTX849) at #RomeLung22, summarizing the KRYSTAL-1 data presented by Drs. @oncoOuLungCA and Pasi Janne. It is a distinct molecule from sotorasib and resistance will differ. Will CNS efficacy be greater with adagrasib? #LCSM (Twitter) - May 16, 2022
- ||| What is the future for #KRAS development? Apart from combinations with sotorasib and adagrasib, some emerging agents showing promise, including JDQ443, VS-6766, and BI 1701963. Outlined at #RomeLung22 by Dr. Paolo Bironzo. (Twitter) - May 16, 2022
- ||||| Lumakras (sotorasib) / Amgen
Biomarker, Clinical: Dr. Silvia Novello recaps the activity of AMG 510 (sotorasib) in #KRAS G12C NSCLC at #RomeLung22. A clear new standard and ongoing combination studies may prove even more exciting. Closes by reminding us of the need to ensure proper biomarker testing for all patients! (Twitter) - May 16, 2022
- | Lumakras (sotorasib) / Amgen, VIC-1911 / VITRAC Therap
New P1 trial, Combination therapy, Monotherapy: VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 15, 2022
P1, N=140, Not yet recruiting, Sponsor: Vitrac Therapeutics, LLC
- | Lumakras (sotorasib) / Amgen
Journal: Profiling Oncogenic Ras Mutant Drugs with Homogeneous Bioluminescent Immunoassays. (Pubmed Central) - May 14, 2022
Activating KRAS mutations present in many cancers are difficult to target with drugs until recently with the FDA approval of sotorasib (AMG-510), a KRAS G12C selective inhibitor...Unlike current assays that require lengthy sample preparation and multiple washing steps, the Lumit immunoassay provides an alternative platform because it is homogeneous and allows to decipher signaling pathways activities in a fast and simple manner. Our results demonstrate that this bioluminescent technology can be adapted to any signaling pathway node, allowing scientists to streamline the analysis of signaling pathways of interest such as Ras, and identify much needed inhibitors of its mutants.
- | adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Journal: Inside the cracked kernel: establishing the molecular basis of AMG510 and MRTX849 in destabilising KRASG12C mutant switch I and II in cancer treatment. (Pubmed Central) - May 12, 2022
These interactions together with pi-pi stacking, pi-sigma and pi-alkyl interactions induced unfolding of switch I whiles compacting switch II, which could interrupt the binding of effector proteins to these interfaces. These insights present useful atomistic perspectives into the success of AMG510 and MRTX849 which could guide the design of more selective and potent KRAS inhibitors.Communicated by Ramaswamy H. Sarma.
- Lumakras (sotorasib) / Amgen
Evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated colorectal cancer: Exploratory plasma biomarker analysis of CodeBreaK 100 (Auditorium A; Level 0) - May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_526;
New RTK alterations frequently emerged at progression, highlighting the potential role for combining sotorasib with upstream inhibitors of RTK, such as SHP2 or EGFR inhibitors. Serial plasma DNA analysis revealed acquired resistance patterns that support the development of KRAS G12C inhibitor combination therapies.
- Lumakras (sotorasib) / Amgen
Rare Genomic Alterations Including Mutations and Fusions and Discussant (Auditorium A; Level 0) - May 12, 2022 - Abstract #ESMOGI2022ESMO_GI_6;
Serial plasma DNA analysis revealed acquired resistance patterns that support the development of KRAS G12C inhibitor combination therapies. Learning Objectives: SO-39: Evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated colorectal cancer: Exploratory plasma biomarker analysis of CodeBreaK 100 - Hans Prenen, et al
- || Lumakras (sotorasib) / Amgen
The #PRWHealthcareAwardsUS winner for Best Pharmaceutical Product Launch (Non-OTC) is @Amgen, @Omnicom Public Relations Group and Substance for Launching First-in-Class Lumakras with Best-in-Class Communications. Congratulations! (Twitter) - May 10, 2022
- |||| Vectibix (panitumumab) / Amgen, Stivarga (regorafenib) / Bayer, Lumakras (sotorasib) / Amgen
Enrollment open: CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov) - May 8, 2022
P3, N=153, Recruiting, Sponsor: Amgen
Learning Objectives: SO-39: Evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated colorectal cancer: Exploratory plasma biomarker analysis of CodeBreaK 100 - Hans Prenen, et al Not yet recruiting --> Recruiting
- || Biomarker, Review, Journal: Biomarker guided treatment in oncogene-driven advanced non-small cell lung cancer in older adults: A Young International Society of Geriatric Oncology Report. (Pubmed Central) - May 8, 2022
Based on currently available data, molecularly-guided therapy for most alterations is safe and efficacious in older adults with oncogene-driven advanced NSCLC. However, for many TKIs, older adult-specific data are lacking, and should be subject of future prospective evaluations.
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Preclinical, Review, Journal, PD(L)-1 Biomarker, IO biomarker: Targeting Mutant Kirsten Rat Sarcoma Viral Oncogene Homolog in Non-Small Cell Lung Cancer: Current Difficulties, Integrative Treatments and Future Perspectives. (Pubmed Central) - May 7, 2022
On the other hand, naturally extracted compounds, which have exhibited safe and effective properties in treating KRAS-mutant NSCLC through suppressing the MAPK and PI3K/AKT/mTOR signaling pathways, as well as through decreasing PD-L1 expression in preclinical studies, could be expected to enter into clinical studies. Finally, in order to confront the matter of drug resistance, the ongoing clinical trials in combination treatment strategies were summarized herein.
- | Lumakras (sotorasib) / Amgen
Preclinical, Journal, IO biomarker: Kirsten rat sarcoma inhibitors in clinical development against nonsmall cell lung cancer. (Pubmed Central) - May 6, 2022
The current review elucidates the development of KRAS inhibitors from basic research to clinical precision medicines. We retrospectively analyze the development of KRAS mutation targeting drugs and discuss the investigations for future development of KRAS inhibitors.
- | adagrasib (MRTX849) / Mirati, ARS-1620 / Kura Oncology, J&J, Araxes Pharma, Lumakras (sotorasib) / Amgen
Journal: Development of a biotin-streptavidin-enhanced enzyme-linked immunosorbent assay (BA-ELISA) for high-throughput screening of KRAS inhibitors. (Pubmed Central) - May 6, 2022
Furthermore, BA-ELISA can also be expanded to determine the cellular potency of the inhibitors using KRAS mutant living cells. Using three previously disclosed compounds, ARS-1620, AMG 510, and MRTX849, we demonstrated that BA-ELISA is a highly sensitive, specific, and robust method for high-throughput screening of KRAS inhibitors.
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Review, Journal: Inhibitors of the GTPase KRAS in cancer: a patent review (2019-2021). (Pubmed Central) - May 6, 2022
With a potentially effective treatment on the horizon, combination strategies could further enhance the efficacy of KRAS-targeted inhibition. Whatever their strengths or limitations, emerging KRAS inhibitors will undoubtedly enrich our understanding of KRAS biology and KRAS-targeted therapy, which will shed light on the development of inhibitors targeting other KRAS mutations.
- | Lumakras (sotorasib) / Amgen
Preclinical, Journal: Absorption, Distribution, Metabolism and Excretion of [C]-Sotorasib in Rats and Dogs: Interspecies Differences in Absorption, Protein Conjugation and Metabolism. (Pubmed Central) - May 6, 2022
Protein adducts with both rat hemoglobin and serum albumin were characterized, explaining observed extended blood and plasma radioactivity profiles. The primary biotransformation pathway, glutathione conjugation, was demonstrated to be mediated through non-enzymatic conjugation in vitro.
- | Lumakras (sotorasib) / Amgen
Journal: Characterization of false positive, contaminant-driven mutagenicity in impurities associated with the sotorasib drug substance. (Pubmed Central) - May 6, 2022
Significant reduction of these contaminants in re-purified batches resulted in no induction of mutagenicity in follow-up GLP micro-Ames tests. In summary, root-cause analyses led to accurate mutagenicity assessment for sotorasib DS-associated impurities.
- |||| Lumakras (sotorasib) / Amgen
Clinical, Adverse events: Case report @ClinicalLung demonstrates effective use of sotorasib in a patient with ESRD on dialysis with advanced #KRAS G12C NSCLC. Used a dose of 240mg daily (960mg is the approved dose), garnering a good response with no reported adverse events. https://t.co/2hIHp0hyAZ (Twitter) - May 6, 2022
- | Lumakras (sotorasib) / Amgen
Retrospective data, Journal: Prevalence of KRAS p.(G12C) in stage IV NSCLC patients in the Netherlands; a nation-wide retrospective cohort study. (Pubmed Central) - May 4, 2022
In summary, root-cause analyses led to accurate mutagenicity assessment for sotorasib DS-associated impurities. The high prevalence for KRAS p.(G12C) offers a promising new specific treatment option for 15% of all stage IV non-squamous NSCLC patients.
- | adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Journal: A saturation mutagenesis screen uncovers resistant and sensitizing secondary KRAS mutations to clinical KRAS inhibitors. (Pubmed Central) - May 3, 2022
Furthermore, we examined the human genetics databases and identified germline or somatic KRAS mutations that appear among the strong resistance hits. Our study positions future drug discovery targeting KRAS toward focusing on inhibitors preserving potency against resistance mutations at key residues.
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Interesting to see how little G12C/Q61H is causing resistance to Sotorasib and Adagrasib. (Twitter) - May 3, 2022
- ||| Lumakras (sotorasib) / Amgen
Enrollment open: A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets (clinicaltrials.gov) - May 3, 2022
P1, N=146, Recruiting, Sponsor: Amgen
Our study positions future drug discovery targeting KRAS toward focusing on inhibitors preserving potency against resistance mutations at key residues. Not yet recruiting --> Recruiting
- Lumakras (sotorasib) / Amgen
Sotorasib (AMG510) in KRAS G12C mutant NSCLC (Gallery B virtually available) - May 1, 2022 - Abstract #OeGHOAHOP2022OeGHO_AHOP_265;
Not yet recruiting --> Recruiting Sponsored By AMGEN
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
#Decoy strategy is a very interesting concept! It may work in programmed sequence of events to lead to the planned outcome. There's a few unplanned outcomes, for example, after targeting a specific #KRAS G12Cm with Adagrasib or Sotorasib. #progression #resistance #transformation (Twitter) - May 1, 2022
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Review, Journal, IO biomarker: KRAS: A Druggable Target in Colon Cancer Patients. (Pubmed Central) - Apr 30, 2022
Drugs targeted to block KRAS effector pathways could be combined with direct KRAS inhibitors, immunotherapy or T cell-targeting approaches in KRAS-mutant tumors. The development of valuable combination regimens will be essential against potential mechanisms of resistance that may arise during treatment.
- adagrasib (MRTX849) / Mirati, IMM-1-104 / Immuneering, Lumakras (sotorasib) / Amgen
Head-to-head comparison of the dual-MEK inhibitor IMM-1-104 versus sotorasib or adagrasib in KRAS mutant pancreatic tumors. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6049;
The Phase 2 KRYSTAL-1 and Phase 1/2 CodeBreaK 100 studies recently reported promising activity in KRAS-G12C PDAC, suggesting an opportunity for disruption of KRAS addiction. IMM-1-104 and sotorasib previously demonstrated comparable tumor regressions in vivo in a KRAS G12C mutant model, MIA PaCa-2 (2021 EORTC).
- Lumakras (sotorasib) / Amgen
Updates on Abstract 360490: First data for sotorasib in patients with pancreatic cancer with KRAS p.G12C mutation: A phase I/II study evaluating efficacy and safety (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5912;
- D3S-001 / D3 Bio
Preclinical characterization of D3S-001, a highly potent, selective, and differentiated covalent inhibitor of KRAS G12C. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5236;
Human PK modeling predicts > 95% constant target blockage using a 200 mg QD dosing regimen, which may be important and relevant to the induction of deeper and more durable clinical response. D3S-001 will enter a first-in-human Phase 1 clinical trial in 2022.
- Lumakras (sotorasib) / Amgen
A pancancer analysis of KRAS alterations in Chinese population. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5232;
Results of CodeBreaK 100 exploratory analysis presented at the 2021 ASCO Annual Meeting showed no significant difference (40% vs 42%) in objective response rates between TMB high (≥ 10 mut/Mb) and TMB low (< 10 mut/Mb). Based on our data, the threshold of TMB high in the Chinese population should be higher.
- Lumakras (sotorasib) / Amgen, Verzenio (abemaciclib) / Eli Lilly
First-in-human phase 1/2 dose escalation and expansion study evaluating first-in-class eIF4A inhibitor zotatifin in patients with solid tumors. (Available On Demand; 73) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5118;
P1/2
eIF4A inhibitor zotatifin achieves pharmacologically relevant exposures with on-target AEs that are manageable at the MTD, with evidence of target knockdown from on-treatment biopsies. Part 2 indication-specific expansions (including in ER+ FGFR-amplified MBC as single agent, ER+ MBC in combination with fulvestrant and abemaciclib, and KRAS NSCLC in combination with sotorasib) are on-going.
- Lumakras (sotorasib) / Amgen
Largest evaluation of acquired resistance to sotorasib in KRAS p.G12C-mutated non–small cell lung cancer (NSCLC) and colorectal cancer (CRC): Plasma biomarker analysis of CodeBreaK100. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5025;
P1/2
New RTK pathway alterations frequently emerged at progression, highlighting the potential role for combining sotorasib with upstream inhibitors of RTK, such as SHP2 or EGFR inhibitors. Serial plasma DNA analysis revealed acquired resistance patterns that support the development of KRASG12C inhibitor combination therapies.
- Lumakras (sotorasib) / Amgen
Trial in progress: A phase 2 study of sotorasib as first-line treatment in patients with stage IV non–small cell lung cancer (NSCLC) whose tumors harbor a KRAS p.G12C mutation (CodeBreaK 201). (Available On Demand; 129b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2914;
P2
Enrollment began in January 2022 and is ongoing. Contact Amgen Medical Information for more information.
- avutometinib (VS-6766) / Verastem, Lumakras (sotorasib) / Amgen
A phase 1/2 study of VS-6766 (RAF/MEK clamp) in combination with sotorasib (G12C inhibitor) in patients with KRAS G12C mutant non–small cell lung cancer (NSCLC) (RAMP 203). (Available On Demand; 128b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2912;
P1, P1/2
Furthermore, acquired mutations and amplifications in the RAS pathway occur clinically upon progression on sotorasib or adagrasib...In vivo, combination of VS-6766 with sotorasib induced strong tumor regressions in contrast to sotorasib monotherapy or sotorasib plus trametinib...Patients enrolled must have histologic or cytologic evidence of NSCLC, measurable disease according to RECIST V1.1 and known KRAS G12C mutation. The study will enroll up to 121 patients with a minimum of 6 and a maximum of 12 patients in Part A and an additional 109 patients in Part B (minimum of 41 patients at RP2D stage 1 for cohort 1 and 2 or RP2D stages 1 and 2 in both cohorts).
- Lumakras (sotorasib) / Amgen
A phase Ib/II study of sotorasib combined with chemotherapy for second-line treatment of KRAS p. G12C–mutated advanced pancreatic cancer. (Available On Demand; 162a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2029;
The secondary endpoint to evaluate safety, and further evaluate efficacy in terms of disease control rate, duration of response, progression-free survival and overall survival. Correlative endpoints will determine biomarkers based on analysis of blood and/or tumor on study.
- || Lumakras (sotorasib) / Amgen
Clinical, Journal, Companion diagnostic: Clinical validation of Guardant360 CDx as a blood-based companion diagnostic for sotorasib. (Pubmed Central) - Apr 27, 2022
Comprehensive genotyping for all therapeutic targets including KRAS p.G12C is critical for management of NSCLC. Liquid biopsy using Guardant360 CDx has clinical validity for identification of patients with KRASp.G12C-mutant NSCLC and, augmented by tissue testing methodologies as outlined on the approved product label, will identify patients for treatment with sotorasib.