Sotorasib

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor & who have progressed on a KRAS G12C inhibitor. The trial is expected to start at the …

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer Read More »

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC

Shots: The companies collaborated to evaluate the synergistic effects of BI 1701963 (SOS1::pan-KRAS inhibitor) + Lumakras (KRAS G12C inhibitor) in a P-I trial for adult patients with LA or metastatic NSCLC The companies will jointly share costs & manage the clinical development for combined therapy. Amgen will sponsor the trial The preclinical data showed that …

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC Read More »

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, …

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Read More »

NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and …

NHS fast tracks access to Amgen’s just-approved KRAS cancer drug Read More »

Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy

Shots: The approval is based on the CodeBreaK 100 trial evaluating the efficacy & tolerability of Lumakras (960mg, qd) in 124 patients with KRAS G12C mutation-positive NSCLC whose disease had progressed after prior treatment with immunotherapy or CT Results: ORR (36%); DCR (81%); mDoR (10 mos.); durable response with a positive benefit-risk profile, 9% showed …

Amgen’s Lumakras (sotorasib) Receives the US FDA’s Approval as the First KRAS Blocking Cancer Therapy Read More »

Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in 126 patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The findings will be presented at the IASLC 2020 WCLC Presidential Symposium The company is currently recruiting in a P-III study (CodeBreaK …

Amgen’s Sotorasib Receives NMPA’s Breakthrough Therapy Designation in China for the Treatment of Advanced NSCLC With KRAS G12C Mutation Read More »

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC

Shots: The P-II cohort of the CodeBreaK 100 clinical study involves assessing Sotorasib (AMG 510, 960mg, qd) in 126 patients with KRAS G12C-mutated advanced NSCLC. The findings will be presented at the IASLC 2020 WCLC Results: @median follow up of 12.2 mos., ORR (37.1%); DCR (80.6%); mDoR (10 mos.), PFS (6.8 mos.). Median tumor shrinkage …

Amgen Report Results of Sotorasib in P-II Study for KRAS G12C-Mutated Advanced NSCLC Read More »

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots: The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy The study provided durable anticancer activity with a positive benefit-risk profile The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures …

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation Read More »

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Shots: The BT designation is based on P-II CodeBreaK 100 study assessing Sotorasib in patients with advanced NSCLC with KRAS G12C mutation whose cancer had progressed despite prior treatment with CT and/or immunotherapy The company is currently recruiting in a P-III study (CodeBreaK 200) assessing sotorasib vs docetaxel in patients with KRAS G12C-mutated NSCLC. Amgen …

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation Read More »

Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target

The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer

Shots: The P-ll CodeBreaK 100 study involves assessing of Sotorasib (proposed INN for AMG 510, 960mg) in 126 patients with KRAS G12C-mutant advanced NSCLC, whose cancer had progressed despite prior treatment with CT and/or immunotherapy Result: ORR is consistent with previously reported P-I study while other measures of efficacy including DoR are promising and 50%+ …

Amgen Report Results of Sotorasib in P-II CodeBreaK 100 Study for Advanced Non-Small Cell Lung Cancer Read More »