 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
| «12...56789101112131415...3839» |
- Margenza (margetuximab) / MacroGenics, ZAI Lab, Lumakras (sotorasib) / Amgen
No checkmate in metastatic setting: Navigating real world patients applying personalized therapy based on extensive tumor profiling. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_4730;
ETP offers a chance for a majority of late stage patients often characterized by visceral crisis to prolong PFS with acceptable ECOG status. ETP is a milestone as cancer itself is a complex disease with the need for complex solutions.
- Lumakras (sotorasib) / Amgen
Biomarker subgroup analyses of CodeBreaK 200, a phase 3 trial of sotorasib versus (vs) docetaxel in patients (pts) with pretreated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). (Live Stream | Hall D1) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3596;
P3
No predictive biomarkers were confirmed, but novel hypothesis-generating signals were observed. Clinical trial information: NCT04303780.
- Lumakras (sotorasib) / Amgen
The primary endpoint analysis of SCARLET study: A single-arm, phase II study of sotorasib plus carboplatin-pemetrexed in patients with advanced non-squamous, non-small cell lung cancer with KRAS G12C mutation (WJOG14821L). (Live Stream | Hall D1) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3594;
Sotorasib in combination with CBDCA/PEM demonstrated favorable ORR and tolerability in advanced non-Sq, NSCLC patients with KRAS G12C mutation. Clinical trial information: jRCT2051210086.
- Lumakras (sotorasib) / Amgen
Intracranial efficacy of sotorasib versus docetaxel in pretreated KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC): Practice-informing data from a global, phase 3, randomized, controlled trial (RCT). (Live Stream | Hall D1; Poster Bd # 4) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3574;
P3
These results suggest IC activity with sotorasib to complement the overall PFS benefit observed with sotorasib versus docetaxel. Clinical trial information: NCT04303780.
- Lumakras (sotorasib) / Amgen
ECOG-ACRIN LUNG-MAP S1900E substudy: A phase II study of sotorasib in participants (Pts) with previously treated stage IV or recurrent KRAS G12C mutant non-squamous (Non-sq) non-small cell lung cancer (NSCLC). (On Demand | Hall A; Poster Bd # 129a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3551;
P2, P2/3
Sotorasib has also demonstrated superiority to docetaxel in the randomized phase III CodeBreaK 200 study (de Langen et al Lancet...Enrollment started April 2 2021 with conservative accrual targets met, currently with 72% enrolled (84/116) as of Feb 14 2023, including 37, 16, and 31 pts, in cohorts 1, 2, and 3, respectively. Clinical trial information: NCT04625647.
- Lumakras (sotorasib) / Amgen, VIC-1911 / VITRAC Therap
A phase 1a/1b study of aurora kinase A inhibitor VIC-1911 as monotherapy and in combination with sotorasib for the treatment of KRAS G12C-mutant non (On Demand | Hall A; Poster Bd # 127b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3548;
P1a/1b
Pharmacodynamics will be determined from ctDNA and tumor biomarker analysis. Clinical trial information: NCT05374538.
- defactinib (VS-6063) / Verastem, avutometinib (VS-6766) / Verastem
RAMP 202: A phase 2 study of avutometinib (VS-6766) (On Demand | Hall A; Poster Bd # 88) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3509;
P2
In this heavily pretreated population of patients with KRAS G12V mt NSCLC, limited clinical activity was observed with combination therapy. While no new safety signals were identified, criteria to proceed to part B were not met, and further evaluation of avutometinib
- Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
The impact of PD-L1 expression and co-mutations on outcome of KRAS-driven non-small-cell lung cancer. (On Demand | Hall A; Poster Bd # 78) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3499;
KEAP1, but not STK11 mutations are associated with impaired benefit from (CHT-)IO in KRASmut NSCLC. Treatment of KRASmut NSCLC after chemo-immunotherapy represents an unmet medical need.
- Lumakras (sotorasib) / Amgen
Clinical and genomic predictors of response and toxicity to sotorasib in a real-world cohort of patients with advanced KRAS G12C-mutant non-small cell lung cancer. (On Demand | Hall A; Poster Bd # 71) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3492;
Severe toxicity was almost exclusively associated with recent ICI exposure. These observations may help further guide sequencing of sotorasib and may help inform the next generation of KRAS G12C clinical trials.
- Vectibix (panitumumab) / Amgen, Takeda, Lumakras (sotorasib) / Amgen
Sotorasib (Soto) plus panitumumab (Pmab) and FOLFIRI for previously treated KRAS G12C-mutated metastatic colorectal cancer (mCRC): CodeBreaK 101 phase 1b safety and efficacy. (Live Stream | Hall D2; Poster Bd # 213) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3161;
P1b/2
Adverse events were manageable and consistent with the expected safety profile of the drugs used, and there was no clinically meaningful Soto and irinotecan PK interaction. Clinical trial information: NCT04185883.
- Lonsurf (trifluridine/tipiracil) / Servier, Otsuka, Stivarga (regorafenib) / Bayer, Lumakras (sotorasib) / Amgen
Matching-adjusted indirect treatment comparisons (MAIC) of sotorasib vs trifluridine/tipiracil (T/T) and regorafenib as monotherapy in chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). (On Demand | Hall A; Poster Bd # 260) - Apr 26, 2023 - Abstract #ASCO2023ASCO_3079;
P1/2, P3
The analyses suggest that sotorasib monotherapy is associated with a statistically significant and clinically meaningful improvement in response rates, PFS and OS vs. T/T and regorafenib in heavily pretreated chemorefractory KRAS G12C-mutated mCRC patients. The analyses are limited by the decreased sample size for sotorasib, the lack of KRAS G12C-specific data in SOC studies, and the impact of differences in post-progression treatments on OS across studies.
- Nerofe (84AA-API 14AA) / Immune System Key
Phase I study of NEROFE and doxorubicin in KRAS-mutated ST2-positive solid tumors. (On Demand | Hall A; Poster Bd # 507a) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2432;
P1
Enrollment to DL1 began in Q1 2023 (NCT05661201). Clinical trial information: NCT05661201.
- Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
SPARK, studying pathways of resistance in KRAS-driven cancers: A remote plasma ctDNA participation study to identify mechanisms of resistance to KRAS inhibitors. (Available On Demand; Poster Bd # 357b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1865;
P=N/A
The study activated on November 1st 2022. Clinical trial information: NCT05272423.
- SOS1 degrader / BioTheryX
Development of bifunctional CRBN-SOS1 degraders for treatment of mutant KRAS cancers. (On Demand | Hall A; Poster Bd # 349) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1851;
Strong synergistic antiproliferative effects were observed when SOS1 degraders were co-treated with KRAS inhibitors AMG510 (G12C) and MRTX1133 (G12D) in respective KRAS-mutant cell lines as well as with MEK inhibition and EGFR inhibition. Together, these results highlight the potential of SOS1 degraders alone and in combination as therapeutic options for a variety of KRAS-driven cancers.
- Lumakras (sotorasib) / Amgen
Early assessment of sotorasib for treatment of patients with advanced non-small cell lung cancer using real-world data in the United States. (On Demand | Hall A; Poster Bd # 154) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1510;
This early analysis suggests that sotorasib does not provide survival benefit at 6-months follow-up. Sotorasib is associated with increased GI-related severe adverse events.
- MRTX1133 / Mirati, Lumakras (sotorasib) / Amgen
Impact of novel pan-RAS inhibitors on efficacy and resistance to AMG-510 and MRTX-1133 in pancreatic cancer cell lines. (Available On Demand; Poster Bd # 476) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1281;
Recently, several mutant KRAS-targeted therapies (sotorasib and adagrasib) have been developed and show promise in PDAC patients. We have developed a series of novel RAS inhibitors that directly bind preferentially to mutant KRAS that may serve as new mutant KRAS-targeted therapeutics, and that may also have the potential to enhance the efficacy or suppress the resistance of AMG-510 and MRTX-1133.
- |||| Lumakras (sotorasib) / Amgen
Circulating tumor DNA: 2yr outcomes from CodeBreaK100: Sotorasib in KRAS G12C-Mt NSCLC @JCO_ASCO: - 174pts - ORR 41%, mDOR 12.3m - mPFS 6.3m, mOS 12.5m - 2yr OS rate 33% - improved outcome assoc w ⬇️baseline ctDNA levels @OncoAlert #LCSM https://t.co/qF7Ed2rcgl (Twitter) - Apr 26, 2023
- |||| Lumakras (sotorasib) / Amgen
Clinical: Now @JCO_ASCO: 2-year analysis of sotorasib in 174 pts with #KRAS G12C NSCLC from CodeBreaK 100. RR 41%, mDOR 12.3m, mPFS 6.3m, mOS 12.5m, 2y OS rate 33%, 23% with PFS ≥1y. Long term benefit just as likely with or without STK11 comutation. https://t.co/4lK27cP9G3 (Twitter) - Apr 25, 2023
- | Lumakras (sotorasib) / Amgen
Trial completion date, Trial primary completion date, Metastases: CodeBreaK 201: A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment (clinicaltrials.gov) - Apr 21, 2023
P2, N=42, Active, not recruiting, Sponsor: Amgen
We have developed a series of novel RAS inhibitors that directly bind preferentially to mutant KRAS that may serve as new mutant KRAS-targeted therapeutics, and that may also have the potential to enhance the efficacy or suppress the resistance of AMG-510 and MRTX-1133. Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: May 2024 --> Aug 2024
- | Journal: Targeting of SOS1: from SOS1 Activators to Proteolysis Targeting Chimeras. (Pubmed Central) - Apr 19, 2023
The first inhibitor, BI-1701963, is in clinical studies alone or in combination with a KRAS inhibitor, a MAPK inhibitor or chemotherapeutics...This PROTAC exhibited the highest SOS1-directed activity due to target destruction, recycling and removal of SOS1 as a scaffolding protein. Although other first PROTACs have entered clinical trials, each conjugate must be meticulously adapted as an efficient clinical drug.
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
New P2 trial, Metastases: Ladarixin With Sotorasib in Advanced NSCLC - Phase II (clinicaltrials.gov) - Apr 18, 2023
P2, N=28, Not yet recruiting, Sponsor: NYU Langone Health
- | Lumakras (sotorasib) / Amgen, ladarixin (DF-2156A) / Dompe
New P1 trial, New P1/2 trial, Metastases: Ladarixin With Sotorasib in Advanced NSCLC (clinicaltrials.gov) - Apr 18, 2023
P1, N=12, Not yet recruiting, Sponsor: NYU Langone Health
- | CYH33 / HaiHe Biopharma, Lumakras (sotorasib) / Amgen
Journal: Targeting PI3K? overcomes resistance to KRas inhibitors mediated by activation of EGFR and/or IGF1R. (Pubmed Central) - Apr 18, 2023
Taken together, these findings revealed the potential mechanism rendering acquired resistance to KRas inhibitors and provided a mechanistic rationale to combine PI3K? inhibitors with KRas inhibitors for therapy of KRAS-mutant cancers in future clinical trials.
- ||| Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
Simultaneous #AACR23 publication in @CD_AACR from @FSkoulidis et al on the largest cohort to date of #KRAS G12C NSCLC treated with sotorasib and adagrasib (n=424). Co-alterations in KEAP1, SMARCA4, CDKN2A poor predictors. Need novel combinations here. https://t.co/IHxEihjIkm (Twitter) - Apr 17, 2023
- |||||| Krazati (adagrasib) / Mirati, RMC-9805 / Revolution Medicines, Lumakras (sotorasib) / Amgen
Preclinical: What is the limit between oncogene addiction and immune addiction? RMC-9805, a Kras-ON inhibitor (adagrasib and sotorasib are Kras-OFF) is not active in Kras-mut immunodeficient mice. Immune system is crucial to drive TKIs responses. @AACR #AACR2023 (Twitter) - Apr 17, 2023
- |||| metformin / Generic mfg., Lumakras (sotorasib) / Amgen
Sotorasib plus metformin in NSCLC Abstract #1078. #AACR23, @LatinxOncology. @UToracica @ogarrieta @josemarialucio @maritza_rramos (Twitter) - Apr 16, 2023
- ||||| Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
The #OncoAlertTopTweet 🚨 Day2⃣of @AACR #AACR23 Tweet by our @OncoAlert faculty @christine_lovly 🇺🇸 Dr. Janne from @DanaFarber summarizes #KRAS G12C inhibitors across numerous cancers. Current approvals of sotorasib + adagrasib in #lungcancer 🫁 best, @weoncologists (Twitter) - Apr 15, 2023
- ||||||| Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
Clinical, Preclinical: Dr. Pasi Janne from @DanaFarber summarizes #KRAS G12C inhibitors across numerous cancers. Current approvals of sotorasib + adagrasib in #lungcancer. Efficacy varies across tumors of different origins and is limited by acquired resistance. #AACR23 @AACR @OncoAlert #LCSM (Twitter) - Apr 15, 2023
- | Lumakras (sotorasib) / Amgen
Journal, Metastases: Kras oncogene ablation prevents resistance in advanced lung adenocarcinoma. (Pubmed Central) - Apr 4, 2023
Instead, sotorasib resistant tumors displayed amplification of the mutant Kras allele and activation of xenobiotic metabolism pathways, suggesting that reduction of the on-target activity of KRASG12C inhibitors is the main mechanism responsible for the onset of resistance. In sum, our results suggest that resistance to KRAS inhibitors could be prevented by achieving a more robust inhibition of KRAS signaling mimicking the results obtained upon Kras ablation.
- ||| Lumakras (sotorasib) / Amgen
Interesting case in #JTOCRR of #KRAS G12C NSCLC with de novo #SCLC transformation from adenocarcinoma but both components responded to sotorasib. @JTOonline Need to learn more here. Note - this has *not* been my experience with transformed #EGFR NSCLC. https://t.co/SZfUA1apqI (Twitter) - Apr 3, 2023
- | vociprotafib (RMC-4630) / Revolution Medicines
Enrollment closed, Trial primary completion date: RMC-4630-03: Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies (clinicaltrials.gov) - Apr 3, 2023
P2, N=47, Active, not recruiting, Sponsor: Revolution Medicines, Inc.
In sum, our results suggest that resistance to KRAS inhibitors could be prevented by achieving a more robust inhibition of KRAS signaling mimicking the results obtained upon Kras ablation. Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2023 --> Sep 2023
- || Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
amoung other limitations, we found (w/ @VPrasadMDMPH) a very unusual and bizarre QoL assessement within CodeBreaK 200 : Day 5 ⁉️ let's think about it: what is the worst day after docetaxel ? ➡️Day 5 captures the low point of chemotherapy, but is a random day of sotorasib. (Twitter) - Mar 30, 2023
- || 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) - Mar 27, 2023
P1/2, N=713, Active, not recruiting, Sponsor: Amgen
Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2023 --> Sep 2023 Trial completion date: May 2026 --> May 2027
- Keytruda (pembrolizumab) / Merck (MSD), Lumakras (sotorasib) / Amgen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Carcinoma Masquerading as Immune Checkpoint Inhibitor Pneumonitis (Walter E. Washington Convention Center, Area D, Hall C (Lower Level)) - Mar 25, 2023 - Abstract #ATS2023ATS_7382;
The patient partially improved with steroid administration which supported the diagnosis of ICI pneumonitis; However, symptoms progressed, and it was found on lung biopsy that patient has lepidic growth adenocarcinoma. Progression of lung cancer should remain on differential diagnosis in those with diffuse pulmonary infiltrates with history of lepidic growth adenocarcinoma.
- || Lumakras (sotorasib) / Amgen
Trial completion date, Trial primary completion date, Monotherapy: CodeBreak101: Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (clinicaltrials.gov) - Mar 24, 2023
P1b/2, N=1143, Recruiting, Sponsor: Amgen
Progression of lung cancer should remain on differential diagnosis in those with diffuse pulmonary infiltrates with history of lepidic growth adenocarcinoma. Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Feb 2026 --> Jul 2026
- || Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
Fascinating & exciting for the Pt🙏 👉In non-regulated world, I would: 1) Start adagrasib or sotorasib + anti-EGFR (based on @RonaYaeger 's CRC data) 2) Meanwhile, if there were SOME WAY to check - I would confirm biallelic loss of BRCA2, and only if LOH, used a PARP inh later (Twitter) - Mar 23, 2023
- || Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
I would have expected a slightly higher TMB in a true HRD-PDAC, ~10% gBRCA do not have biallelic inactivation in our experience, would ascertain platinum response first +/- PARPi ! favour adagrasib over sotorasib https://t.co/rMiPJ9l9RE (Twitter) - Mar 23, 2023
- |||| Krazati (adagrasib) / Mirati, Lumakras (sotorasib) / Amgen
Clinical: The Immmunotherapy➕#KRASG12C⛔️ while sounds attractive, there were cases of immune hepatitis👇🏾. Seen a few myself. I believe I saw a discussion about this maybe drug not class specific? Seen with sotoRASib but not adagRASib. @JackWestMD @StephenVLiu 💭 https://t.co/M2f2Ge0O3O (Twitter) - Mar 23, 2023
- || Lumakras (sotorasib) / Amgen, Lynparza (olaparib) / Merck (MSD), AstraZeneca
This is what we would do. Sotorasib plus olaparib; start each at half dose and titrate to tolerance (Twitter) - Mar 23, 2023
- |||| Clinical: A 12-4. G12Ci Combi recruiting #clinicaltrials 📌CodeBreak 300 https://t.co/5lOD1uqMFD 📌2L 📌Ph III 📌n=153 📌AMG510 (KRAS G12Ci) 2 diff doses + Vectibix vs TAS102 or Regorafenib 📌PFS end point 📌Exclusion: Prior G12Ci & active brain mets #CRCTrialsChat #CRCSM @OncoAlert (Twitter) - Mar 23, 2023
- ||| Lumakras (sotorasib) / Amgen, irinotecan / Generic mfg.
Clinical: 1. mFOLFIRINOX 2. PARPi maintenance / 3. GemCis, 4. Sotorasib (Twitter) - Mar 23, 2023
- |||| Vectibix (panitumumab) / Amgen, Stivarga (regorafenib) / Bayer, Lumakras (sotorasib) / Amgen
Enrollment closed: CodeBreak 300: Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation (clinicaltrials.gov) - Mar 23, 2023
P3, N=160, Active, not recruiting, Sponsor: Amgen
Trial completion date: Apr 2028 --> Jan 2029 | Trial primary completion date: Feb 2026 --> Jul 2026 Recruiting --> Active, not recruiting
- ||| Biomarker, Clinical: Little chance of prolonged survival even with sotorasib. KRAS mutation by itself a poor prognostic factor. Hoping that HRD score is high start with FOLFIRINOX and keep gem cis +/- PARPi as second line therapy. Is there dMMR ? (Twitter) - Mar 22, 2023
- ||| Krazati (adagrasib) / Mirati, Keytruda (pembrolizumab) / Merck (MSD), Lumakras (sotorasib) / Amgen
This is sotorasib data. We have now data from adagrasib plus pembro and it seems to be better tolerated. So, post IO if you have to use KRAS G12C inhibitor, we favor adagrasib these days… (Twitter) - Mar 20, 2023
- |||| Lumakras (sotorasib) / Amgen
Ahhh… this is the abstract/poster I was referring to: “We suggest an excess of immune-mediated AE with sequential sotorasib following anti-PD(L)1” though as you can see, #chatgpt4 is not keen on this idea! #lcsm (Twitter) - Mar 20, 2023
- |||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Presidential session @JSMO_official. Prof. Isamu Okamoto presented Sotorasib versus Docetaxel for Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation: CodeBreaK 200. FREE on-demand access for international audiences! https://t.co/FOoy0D4CKL #JSMO2023 #LCSM (Twitter) - Mar 17, 2023
- ||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Presidential session @JSMO_official. Prof. Isamu Okamoto presented Sotorasib versus Docetaxel for Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation: CodeBreaK 200. FREE on-demand access for international audiences! https://t.co/M3njqk44vJ #JSMO2023 #LCSM (Twitter) - Mar 17, 2023
- | Biomarker, Enrollment open: Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (clinicaltrials.gov) - Mar 17, 2023
P2, N=2900, Recruiting, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Krazati (adagrasib) / Mirati, MRTX1133 / Mirati, Lumakras (sotorasib) / Amgen
Journal: Glimmers of hope for targeting oncogenic KRAS-G12D. (Pubmed Central) - Mar 16, 2023
Recently, through extensive structure-based drug design from Mirati Therapeutics, a novel non-covalent KRAS-G12D inhibitor, MRTX1133, showed significant preclinical antitumor activity in KRAS-G12D-bearing tumor cells, especially pancreatic ductal adenocarcinoma. Here, we discuss the selectivity, efficacy, toxicity, and potential application challenges of this novel targeted protein inhibitor.