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- Verzenio (abemaciclib) / Eli Lilly
Abemaciclib drug combination screening with other targeted therapies in complex multicellular tumor spheroids (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_314;
The most effective combination for abemaciclib was with the CDK2/7/9 inhibitor BMS-387032, which achieved greater than one log of cytotoxicity in the majority of the complex spheroid models...HHSN261201500003I. No
- adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Ornithine decarboxylase as a new target for improving the effect of KRAS-G12C inhibitors in non-small cell lung cancer cells (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_308;
Funding: FONDECYT-ANID #1201378 grant. No
- adagrasib (MRTX849) / Mirati, Fyarro (nanoparticle albumin-bound rapamycin) / Aadi Biosci, Lumakras (sotorasib) / Amgen
KRAS G12C mutated NSCLC and bladder cancer xenografts treated with sotorasib and adagrasib in combination with mTOR inhibitors show improved antitumor activity of nab-sirolimus vs everolimus (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_302;
Combining mTOR inhibition with KRAS G12C inhibition improves response against tumors in vivo. nab-Sirolimus showed greater potency compared to everolimus and is the preferred agent for further clinical development using this strategy.
- Zarnestra (tipifarnib) / Kura Oncology
Using Tipifarnib to prevent resistance to targeted therapies in oncogene-addicted tumors (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_292;
Similar to what was observed in EGFR-TKi-treated NSCLC, some cells, referred to as "early escapers", could escape G1 and progress through S/G2 during the initial response phase, progressively giving rise to resistant proliferative clones. Co-treatment with tipifarnib prevented relapse in all the models tested by impairing mitosis of S/G2 early escapers and promoting apoptosis.
- ABSK071 / Abbisko
Discovery and characterization of ABSK071, a novel and potent small-molecule covalent inhibitor for KRAS-G12C (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_218;
In vivo efficacy studies showed that ABSK071 has higher anti-tumor potency than sotorasib at the same dose in multiple xenograft models. Together, these data demonstrated the antitumor activity of ABSK071 towards KRASG12C-dependent cancers.
- avutometinib (VS-6766) / Verastem
The RAF/MEK clamp VS-6766 shows strong anti-tumor activity acrossmultiple MAPK pathway alterations, with a preferential effect on KRASG12V (Exhibition Hall) - Sep 3, 2022 - Abstract #AACRNCIEORTC2022AACR_NCI_EORTC_209;
P1/2, P2
Together, these data demonstrated the antitumor activity of ABSK071 towards KRASG12C-dependent cancers. These data support the ongoing registration-directed studyevaluating VS-6766 ± defactinib for patients with KRAS G12 V NSCLC(NCT04620330), as well as the clinical combinations of VS-6766 with theKRAS G12C inhibitors sotorasib (NCT05074810) or adagrasib(NCT05375994) for KRAS G12C NSCLC.
- |||| Lumakras (sotorasib) / Amgen
P3 data: Great list. I would add #sotorasib phase III to it, which was recently added to the program of #ESMO22. (Twitter) - Sep 3, 2022
- || adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Review, Journal, IO biomarker: KRAS-Mutant Non-Small-Cell Lung Cancer: From Past Efforts to Future Challenges. (Pubmed Central) - Sep 3, 2022
The aim of this review was to analyze the state-of-the-art of KRAS mutations in non-small-cell lung cancer by describing the biological structure of KRAS and exploring the clinical relevance of KRAS as a prognostic and predictive biomarker. We reviewed the different treatment approaches, focusing on the novel therapeutic strategies for the treatment of KRAS-mutant lung cancers.
- || Lumakras (sotorasib) / Amgen
Trial initiation date, Metastases: Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer (clinicaltrials.gov) - Sep 2, 2022
P1/2, N=59, Not yet recruiting, Sponsor: Devalingam Mahalingam
We reviewed the different treatment approaches, focusing on the novel therapeutic strategies for the treatment of KRAS-mutant lung cancers. Initiation date: May 2022 --> Nov 2022
- || 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) - Sep 2, 2022
P1/2, N=793, Recruiting, Sponsor: Amgen
Initiation date: May 2022 --> Nov 2022 Trial completion date: Apr 2026 --> Dec 2025 | Trial primary completion date: Apr 2026 --> Dec 2025
- ||| Lumakras (sotorasib) / Amgen
PFS With Sotorasib Superior to Standard of Care in KRAS G12C-Mutant NSCLC https://t.co/dPqazvubXL via @targetedonc (Twitter) - Sep 1, 2022
- || Lumakras (sotorasib) / Amgen
This discussion is still relevant in countries as Denmark where sotorasib is not reimbursed (Twitter) - Sep 1, 2022
- |||| Lumakras (sotorasib) / Amgen
Let’s see how much liver toxicity sotorasib induces just after immunotherapy. (Twitter) - Sep 1, 2022
- ||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Clinical: Crossover should be permitted, but I think sequence is pretty relevant when we're going from 2nd to 3rd line, where attrition is likely to be an issue. Plenty of pts who progress after 2L sotorasib won't be pursuing 3L docetaxel, & many won't get soto after 2L doce, I expect. (Twitter) - Sep 1, 2022
- ||| Koselugo (selumetinib) / Merck (MSD), AstraZeneca, Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Clinical: Selumetinib + docetaxel (n= 87) ORR 37% PFS 5.3 mo (delta 3.2 vs docetaxel) Sotorasib (n=126) ORR 37% PFS 6.8 mo Later on, positive randomized Ph2 trial of selumetinib turned out negative in a large Ph3 trial Selumetinib + docetaxel (n= 251) ⬇️ORR 20% ⬇️PFS 3.9 mo (Twitter) - Sep 1, 2022
- Lumakras (sotorasib) / Amgen
Evaluation of the UK Innovative Licensing and Access Pathway (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_2543;
Most innovation passports are awarded during early stages of product development, although those at later stages have had a 100% success rate and reduced time for reimbursement. Although ILAP is a fairly new programme, it has shown popularity with 113 applications since January 2021; this may continue as awareness of the programme grows, and more details on the eligibility criteria and benefits of ILAP come to light.
- ||| Lumakras (sotorasib) / Amgen
I would submit that waiting for OS in setting of 2nd line adv NSCLC is immediately relevant & unfortunately not too long to wait on this. If you want to go by PFS alone, you are free to, but many others think it's important to clarify whether sotorasib improves OS or not here. (Twitter) - Sep 1, 2022
- ||||| Lumakras (sotorasib) / Amgen
Clinical: The most interesting men in oncology seem to find this result the least interesting- so: Plainary session? Indeed it seems like a foregone conclusion- sotorasib already established as preferred 2nd line for pts w KRas G12C (Twitter) - Aug 31, 2022
- |||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Some context, the study was sponsored by @AmgenOncology. #KRAS 🫁 #ESMO22 #Sotorasib #Docetaxel https://t.co/vbrRUbcQpb (Twitter) - Aug 31, 2022
- |||| adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
The bar is set low. Mono Sotorasib or Adagrasib is a good step forward, but not spectacular. Few combos disappointed, too. Hopefully, Dr. Ross Camidge @CUCancerCenter @AlexSpiraMDPhD @govindan08 @MLJohnsonMD2 have better luck with RAMP202/203/204 🫁 #KRAS https://t.co/vbrRUbcQpb (Twitter) - Aug 31, 2022
- |||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Clinical, Head-to-Head: Every effective oncogene-targeted therapy in lung cancer has beat chemo in PFS head to head and this was second line docetaxel so a low bar, but still nice to see (if unsurprising). I suspect most already used sotorasib over chemo 2nd line for KRAS G12C+! #LCSM (Twitter) - Aug 31, 2022
- ||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Press release: Sotorasib yields improved PFS over docetaxel in Phase III trial of KRAS G12C+ NSCLC, as anticipated. No actual data presented. No OS data presented. Status quo or a step forward? https://t.co/twhZiEpnvl (Twitter) - Aug 31, 2022
- ||||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Clinical, P3 data: The presentation: "Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study" has just been added to the Presidential session III of #ESMO2022 First randomized trial testing a KRAS inhibitor in NSCLC (Twitter) - Aug 31, 2022
- ||||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
P3 data: CODEBREAK 200 is finally presented at ESMO. A can’t-miss event at #ESMO22 !!! PLENARY SESSION III, Mon 12, presented by @MLJohnsonMD2 🚨 LBA10 - Sotorasib versus docetaxel for previously treated non-small cell lung cancer with KRAS G12C mutation: CodeBreaK 200 phase III study (Twitter) - Aug 31, 2022
- || Lumakras (sotorasib) / Amgen
Enrollment closed: A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers (clinicaltrials.gov) - Aug 31, 2022
P1, N=14, Active, not recruiting, Sponsor: Amgen
Although ILAP is a fairly new programme, it has shown popularity with 113 applications since January 2021; this may continue as awareness of the programme grows, and more details on the eligibility criteria and benefits of ILAP come to light. Recruiting --> Active, not recruiting
- |||||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
Clinical: JUST IN: Phase 3 CodeBreaK 200 trial with Sotorasib met its primary endpoint of PFS over docetaxel. This is the 1st randomized clinical trial for a KRASG12C inhibitor in previously treated patients with KRAS G12C-mutated NSCLC @Amgen @OncoAlert https://t.co/PSpQ0qoPZb (Twitter) - Aug 31, 2022
- ||| Lumakras (sotorasib) / Amgen
my dad has a metastatic non-small cell lung adenocarcinoma, Kras g12c, concluded Sotorasib .... the situation is critical ..... (Twitter) - Aug 30, 2022
- ||| Lumakras (sotorasib) / Amgen
my dad has a metastatic non-small cell lung adenocarcinoma, Kras g12c, concluded Sotorasib .... the situation is critical ..... (Twitter) - Aug 30, 2022
- ||| Lumakras (sotorasib) / Amgen
my dad has a metastatic non-small cell lung adenocarcinoma, Kras g12c, concluded Sotorasib .... the situation is critical ..... (Twitter) - Aug 30, 2022
- ||| Lumakras (sotorasib) / Amgen, docetaxel / Generic mfg.
sotorasib vs docetaxel - the result is a foregone conclusion. The trial of interest would compare initial sotorasib to chemo-immunotherapy or immunotherapy alone in the PDL-1 >49% group (Twitter) - Aug 30, 2022
- | Lumakras (sotorasib) / Amgen
Preclinical, Journal: Mechanistic insights into the clinical Y96D mutation with acquired resistance to AMG510 in the KRAS. (Pubmed Central) - Aug 30, 2022
The resulting departing motion impaired the interaction between the switch II and α3-helix and subsequently induced the opening and loosening of the AMG510 binding pocket, which further disrupted the interaction between the key residues in the pocket and AMG510 and induced an increased solvent exposure of AMG510. These findings reveal the resistance mechanism of AMG510 to KRAS, which will help to offer guidance for the development of KRAS targeted drugs to overcome acquired resistance.
- | Lumakras (sotorasib) / Amgen
$AMGN Lumakras hits on PFS in confirmatory Codebreak-200 trial. No details revealed, but the $MRTX scenario I discussed in Feb is now in play (Twitter) - Aug 30, 2022
- ||||| Lumakras (sotorasib) / Amgen
Clinical: What Are the Benefits of the KRAS G12C Inhibitor Sotorasib? @DavidHongMD from @MDAndersonNews discusses the results of the CodeBreaK 100 clinical trial, which evaluated the efficacy of the KRAS G12C inhibitor sotorasib (Lumakras) in treating NSCLC: https://t.co/STb48i7YZL #lcsm (Twitter) - Aug 25, 2022
- ||| adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
my dad has metastatic non-small cell lung adenocarcinoma with kras g12c mutation, they stopped Sotorasib and said Adagrasib is the same ... I'm desperate (Twitter) - Aug 24, 2022
- ||| Lumakras (sotorasib) / Amgen
We need to rethink IO and sotorasib sequencing ➡️Soto +/- chemo front-line when IO do not work (PD-L1-, TMB low, KEAP1 mut)? ➡️Lower Soto dosage when sequenced/combined with IO? ➡️It may be a therapeutic class effect and it should be anticipated with other KRASG12C inhibitors (Twitter) - Aug 23, 2022
- | Lumakras (sotorasib) / Amgen
Journal: Sotorasib associated with tacrolimus and everolimus: A significant drug interaction in lung transplant patients. (Pubmed Central) - Aug 18, 2022
This imbalance is explained by the fact that sotorasib is an inducer of CYP3A4 and an inhibitor of PGP, but the strength of the interaction has never been studied. This will have required a threefold increase in dosages and weekly monitoring before satisfactory residual levels were achieved.
- || Lumakras (sotorasib) / Amgen
Enrollment open: A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers (clinicaltrials.gov) - Aug 17, 2022
P1, N=14, Recruiting, Sponsor: Amgen
This will have required a threefold increase in dosages and weekly monitoring before satisfactory residual levels were achieved. Not yet recruiting --> Recruiting
- | Lumakras (sotorasib) / Amgen
Journal: Clinical progress of KRAS-targeted therapies: what next? (Pubmed Central) - Aug 17, 2022
Not yet recruiting --> Recruiting No abstract available
- ||||| Lumakras (sotorasib) / Amgen
9a) @IASLC #WCLC22 Dr. Tuns presented (EP16.03-004) Targeting SHP2 Reverts Oncogenic Mediated Resistance to KRASG12C Inhibition ➡️ #HER2 overexpressing #KRASG12C cells resistant to #sotorasib #LCSM: (Twitter) - Aug 16, 2022
- || Lumakras (sotorasib) / Amgen, VIC-1911 / VITRAC Therap
Trial initiation date, Combination therapy, Monotherapy: VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (clinicaltrials.gov) - Aug 16, 2022
P1, N=140, Not yet recruiting, Sponsor: Vitrac Therapeutics, LLC
No abstract available Initiation date: Jun 2022 --> Sep 2022
- Lumakras (sotorasib) / Amgen
Evaluation of acquired resistance to sotorasib in patients with KRAS p.G12C-mutated non-small cell lung cancer: biomarker analysis using plasma from the CodeBreaK 100 trial (Rio) - Aug 16, 2022 - Abstract #ECP2022ECP_859;
This highlights a potential benefit of combining sotorasib with upstream inhibitors of RTK, such as SHP2 or EGFR inhibitors. Overall, pat-terns of acquired resistance suggested by DNA analysis of plasma samples at baseline and disease progression support the develop-ment of KRASG12C inhibitor combination therapies.
- || Lumakras (sotorasib) / Amgen
WCLC2022 CodeBreaK100/101 sotorasib+IO P1b試験 IO併用で肝障害のリスクはあるが、Sotorasib先行で入れることで改善。 奏功を評価できる段階ではないが、water fall plotではそれなりに縮小していそう ＃WCLC22 ＃WCLC2022 ＃KRAS ＃肺がん (Twitter) - Aug 14, 2022
- || Lumakras (sotorasib) / Amgen
Enrollment closed, 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) - Aug 12, 2022
P2, N=170, Active, not recruiting, Sponsor: Amgen
Overall, pat-terns of acquired resistance suggested by DNA analysis of plasma samples at baseline and disease progression support the develop-ment of KRASG12C inhibitor combination therapies. Recruiting --> Active, not recruiting
- | Mekinist (trametinib) / Novartis, Lumakras (sotorasib) / Amgen
Preclinical, Journal, PD(L)-1 Biomarker, IO biomarker: Radiation combined with KRAS-MEK inhibitors enhances anticancer immunity in KRAS-mutated tumor models. (Pubmed Central) - Aug 11, 2022
The expression levels of immune-related genes also increased in the combination therapy group. Our results indicate that KRAS-MEK inhibitors in combination with radiotherapy can enhance antitumor immunity, providing new therapeutic strategies for KRAS-mutated tumors.
- |||| Keytruda (pembrolizumab) / Merck (MSD), Lumakras (sotorasib) / Amgen, Tecentriq (atezolizumab) / Roche
#WCLC22 Catch up Ph I Sotorasib + Atezo/Pembro by Bob Li: - concurrent soto+atezo/pembro (n=29) or lead-in soto for 21/42 days then combo (n=29) - concurrent had signif hepatotox (100% at std soto dose, small nos), lead-in had less Concerning tox, seen before w TKI+IO @IASLC (Twitter) - Aug 11, 2022
- |||||| Lumakras (sotorasib) / Amgen
Clinical: #WCLC22 Catch-up Ph I Sotorasib+SPH2i (RMC-4260, blocks a known resistance mechanism): - 27pts - common tox: oedema, dry mouth - ?efficacy at higher doses of SHP2i - activity in 1L & after prior KRAS G12Ci, but small nos Combo of interest in KRAS G12C-mt NSCLC @IASLC (Twitter) - Aug 11, 2022
- || Lumakras (sotorasib) / Amgen
Trial primary completion date, Metastases: Lung KG12Ci: RW Efficacy of Sotorasib in KRAS G12C-mutated Metastatic NSCLC (clinicaltrials.gov) - Aug 11, 2022
P=N/A, N=300, Recruiting, Sponsor: Intergroupe Francophone de Cancerologie Thoracique
Our results indicate that KRAS-MEK inhibitors in combination with radiotherapy can enhance antitumor immunity, providing new therapeutic strategies for KRAS-mutated tumors. Trial primary completion date: Jun 2022 --> Dec 2022
- || Lumakras (sotorasib) / Amgen
New P1 trial: A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers (clinicaltrials.gov) - Aug 11, 2022
P1, N=14, Not yet recruiting, Sponsor: Amgen
- | adagrasib (MRTX849) / Mirati, Lumakras (sotorasib) / Amgen
Journal: KRAS-targeted therapy in the treatment of non-small cell lung cancer. (Pubmed Central) - Aug 9, 2022
Trial primary completion date: Jun 2022 --> Dec 2022 Further trials need to be conducted in order to identify other targeted agents for KRAS and the appropriate place in therapy among currently approved treatments for non-small cell lung cancer.
- ||| Lumakras (sotorasib) / Amgen
Very proud of my former fellow, Dr. Rakshit who presented data on hepatotoxicity from sotorasib following IO. Increased rates of grade 3 transaminase elevation if IO<3months from sotorasib #WCLC22 (Twitter) - Aug 9, 2022