Pembrolizumab receives NMPA approval as monotherapy in China for 1L PD-L1+ve NSCLC patients
“New treatment options that can help improve survival outcomes are desperately needed in China, as lung cancer remains the leading cause of cancer deaths in this country,” said Professor Yi-Long Wu, honorary director of the Guangdong Lung Cancer Research Institute, and tenured professor of Guangdong Provincial People’s Hospital. “In KEYNOTE-042, KEYTRUDA monotherapy demonstrated a survival benefit, compared with chemotherapy alone, across histologies in patients with either locally advanced or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumor cells.”

Niraparib receives Breakthrough Therapy Designation in previously treated mCRPC patients

• Designation granted on the basis of Ph II GALAHAD trial results (recently presented in ESMO - 2019 meeting)
• With this designation, Niraparib seems to have an edge over other PARP inhibitors in the race
• Niraparib also being tested in 1L mCRPC patients in combination with abiraterone and prednisone in Ph III MAGNITUDE trial
• Other PARP inhibitors in race are: Olaparib (in combination with Pembrolizumab in Ph Ib/II KEYNOTE-365 trial), Rucaparib in TRITON-2 trial (and with a BTD in BRCA1/2-mutated mCRPC patients, too) and Talazoparib in Ph II TALAPRO-1 trial
• PROfound and TRITON-3 trials, on the other hand, are exploring the efficacy of PARP inhibitors in pre-chemo settings

Fast Track Designation granted to Imetelstat for Relapsed/Refractory Myelofibrosis

• FTD granted to imetelstat for the treatment of adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment, or R/R MF
• FTD includes patients with primary MF and MF developed after essential thrombocythemia or polycythemia vera
• End of Phase 2 meeting with the FDA planned by the end of the first quarter of 2020 to determine if there is a regulatory path forward for imetelstat in R/R MF

Ph I/Ib trial of Syk inhibitor HMPL-523 initiated in patients with relapsed or refractory lymphoma

• First patient dosed on September 26, 2019 in the U.S.
• Multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-523 administered orally to patients with relapsed or refractory lymphoma
• Primary outcome measures: safety and tolerability
• Secondary outcomes: pharmacokinetic (PK) measurements and preliminary efficacy such as objective response rate (ORR)

First patient dosed in Ph Ib/II trial of BAVENCIO (avelumab) in multi-drug combinations with CMP-001 in SCCHN patients as part of the JAVELIN Medley study
“The dosing of patients in this trial represents an important milestone for Checkmate as we seek to build upon promising data we have generated to date with CMP-001, particularly in PD-1-refractory advanced melanoma. Based upon the preclinical and clinical work conducted to date, we believe CMP-001 can effectively convert cold tumors to hot and thereby improve response to PD-1/L1-based immunotherapy in a variety of solid tumors. We look forward to the results of this clinical trial,” commented Barry Labinger, President and CEO of Checkmate Pharmaceuticals.
 

Tokyo-based AI Medical Service raise $43 million in series B for endoscopy image analysis
AI Medical Service has raised $43 million in series B to support the clinical trial of its software that analyzes endoscopy images in real time using artificial intelligence for detection of gastric cancer. The investors for current funding include Globis Capital Partners, World Innovation Lan and the Sony Innovation Fund by Innovation Growth Ventures. With multiple Japanese medical institutions, AI Medical Services is set to build a large dataset of endoscopic images.