Amgen's First-in-Class KRAS G12C Inhibitor AMG 510 Shows Promising Early Clinical Data at ASCO 2019

[June 4, 2019 / R&D NEWS]The world’s first KRAS G12C inhibitor stuns the field; Promising results from two pivotal Phase III trials of the anti-inflammatory drug Xolair for chronic rhinitis; Great potential! Bristol Myers Squibb’s Opdivo + Yervoy combination “concentrates fire” against liver cancer; FDA approves Merck’s new therapy for bacterial pneumonia...

We focus on the latest developments in pharmaceutical R&D, providing timely and accurate information for researchers.(Click the title to read the full article)

[Drug Development]

Aisen Pharma Presents Research Findings on Ivetinib for the Treatment of Non-Small Cell Lung Cancer

On the morning of June 2, Chicago time, Aivitinib, China’s first third-generation EGFR-TKI independently developed by Hangzhou Ison Pharmaceutical Research Co., Ltd., was unveiled at the 2019 ASCO Annual Meeting, where clinical study results of its treatment for Chinese patients with EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) were presented.

Promising Results from Two Key Phase III Studies of Anti-Inflammatory Drug Xolair for Chronic Rhinitis

Roche and Novartis recently announced positive topline data from two Phase III studies (POLYP 1 and POLYP 2) evaluating the anti-inflammatory drug Xolair (omalizumab) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).

Amgen’s Stock Surges! The World’s First KRAS G12C Inhibitor Stuns the Industry

On June 3, Amgen presented the first-in-human clinical trial results of AMG 510, the first KRAS G12C inhibitor, in an oral report at the ASCO 2019 conference. This open-label Phase I study enrolled 35 patients with KRAS G12C mutations who had previously received at least two lines of therapy, including 14 patients with non-small cell lung cancer (NSCLC).

Astellas Announces Phase 2 Clinical Data for Investigational Antibody-Drug Conjugate

Seattle Genetics and Astellas Announce Preliminary Phase 2 Clinical Data for Investigational Antibody-Drug Conjugate (ADC) Enfortumab VedotinThe study demonstrated that this ADC achieved a 44% objective response rate in patients with metastatic urothelial carcinoma who had progressed even on immunotherapy. This research was highlighted as a key feature of today’s ASCO Annual Meeting and received special coverage on the conference’s official website.

Great Potential! Bristol Myers Squibb’s Opdivo + Yervoy Combination “Concentrates Fire” Against Liver Cancer

Bristol-Myers Squibb (BMS) recently announced the first data from the Opdivo + Yervoy (OY combination) cohort of the Phase I/II CheckMate-040 study in hepatocellular carcinoma (HCC) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago. The results confirmed the robust efficacy of the combination therapy of Opdivo (Opdivo, generic name: nivolumab) and Yervoy (ipilimumab) in treating HCC.

Ascentage Pharma Announces Clinical Data for Apoptosis Series Products APG-115 and APG-1387

Ascentage Pharma Announces Latest Data from Three Clinical Trials of Two Investigational Apoptosis Products, APG-115 (MDM2-p53 Inhibitor) and APG-1387 (IAP Inhibitor), at the 55th American Society of Clinical Oncology (ASCO) Annual Meeting

Novartis MET Inhibitor Data Released: Response Rate Reaches 68% in Treatment-Naïve Patients

Novartis recently announced new data and clinical trials for the treatment of non-small cell lung cancer (NSCLC), including the primary efficacy results from the Phase II GEOMETYR mono-1 clinical trial, which demonstrated that the investigational MET inhibitor capmatinib (INC280) has potential therapeutic effects for patients with locally advanced or metastatic NSCLC harboring MET exon 14 skipping mutations. Currently, there are no approved targeted therapies available to treat this particularly aggressive form of NSCLC.

[Drug Approval]

FDA Approves MSD’s New Therapy for the Treatment of Bacterial Pneumonia

Today, MSD announced that the U.S. FDA has approved its supplemental New Drug Application (sNDA) for the antibacterial therapy Zerbaxa (ceftolozane/tazobactam) for the treatment of specific bacterial pneumonia in patients aged 18 years and older. In its press release, the FDA stated that this therapy is expected to address an important unmet medical need amid the global crisis of drug-resistant superbugs.

Bluebird Gene Therapy Approved by EU for Treatment of β-Thalassemia

bluebird bio Announces Conditional EU Approval of Gene Therapy ZYNTEGLO for the Treatment of Transfusion-Dependent β-Thalassemia in Patients Aged 12 Years and Older. Notably, ZYNTEGLO is the first gene therapy for this disease.

[Latest Research]

Novel DNA Packaging-Based Blood Test Developed to Detect Multiple Cancers

Researchers at the Johns Hopkins University Kimmel Cancer Center have developed a simple, novel blood test that can detect the presence of seven different types of cancer by identifying unique patterns of DNA fragments shed by cancer cells and circulating in the bloodstream.

Key Links Between Different Cell Types and Arthritis

Recently, scientists from the University of Oxford and the University of Birmingham published a groundbreaking study in Nature, bringing us one step closer to developing targeted therapies for inflammatory diseases.