Biopharmaceutical News Week # 22.2017
Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, email@example.com
Manchester, London, Egypt, Manilla. Coward terrorist attacks once again. We are mourning with our friends and readers around the globe.
Highlights from the Meeting
A combination of Merck’s Keytruda, a PD-1 checkpoint inhibitor, and Incyte’s endocadostat, an indolamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor showed an overall response rate in second-line non-small cell lung cancer which was almost twice as high as Keytruda alone.
A combination of Bristol-Myers Squibb’s Opdivo, a PD-1 checkpoint inhibitor and Yervoy, a CTLA4 inhibitor slowed mesothelioma progression more than Opdivo alone.
Johnson & Johnson reported that a combination of Zytiga with prednisone and androgen deprivation was superior to androgen deprivation at improving survival among patients with high-risk metastatic hormone-naïve prostate cancer.
Roche’s combination of Herceptin with Perjeta to treat post-surgery breast cancer progression was rather disappointed and only 1% higher than Herceptin alone.
AstraZeneca’s Lynparza, a PAPR inhibitor, reduced the risk of breast cancer worsening or death by 42% in a phase 3 study, with a shrinking of tumors in about 60% of patients versus 29% in the ones treated with chemotherapy.
Pfizer’s dacomitinib, was superior to AstraZeneca’s Iressa in delaying EGFR-positive lung cancer, in newly diagnosed patients, in reducing the risk of progression by 41% but was inferior to Roche’s Tarceva.
Eisai reported that Lenvima doubled median progression-free survival time at 7.4 months compared with Bayer Nexavar’s 3.7 months.
Dendreon showed that Provenge, its prostate cancer vaccine generates a killer T-cell response and that the sternght of the response correlates with overall survival.
Juno Therapeutics reported that JCAR017, its CAR-T cell therapy, had positive results on early-stage non-Hodgkin lymphoma with a combined overall response rate of 86% and a complete response rate of 59% (26 out of 44 patients, with 37 out of 38 still alive).
Novartis reports positive response rate in mid-stage lymphoma study with CTL019, a CAR-T cell therapy candidate with nevertheless prevalent side effects. The best overall response rate (OOR) was 59% including 43% complete responders. Globally the ORR was 45% including 37% of complete responders with 57% of patients experiencing cytokine release syndrome a known complication of CAR-T therapy.
Nanjing Legend Biotech (China) released data of its own CAR-T clinical candidate showing positive results to treat relapsed or refractory multiple myeloma.
Sanofi and Regeneron report first results with REGN2810, a PD-1 checkpoint inhibitor, in patients with cutaneous squamous cell carcinoma – the second deadliest form of skin cancer behind melanoma- with an overall response rate of 46;2% (12 in 26 patients) including 2 complete responses and 9 partial responses.
Hutchinson China MediTech reports positive results with fruquinitib in colon cancer and is working on a fast approval in China. Overall survival rate was 9.3 months versus 6.57 months in the placebo arm. The median progression-free survival rate hit 3.71 months compared to 1.84 months for the control group. Chi-Med CEO Christian Hogg indicated, a few months ago, that this is the first time a Chinese biotech has discovered and developed a drug for the Chinese market.
A few days ago, the US FDA had granted approval for Merck’s Keytruda to fight tumors with a biomarker called microsatelillte instability-high or mismatch repair deficient. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location” said Richard Pazdur acting director of the office of hematology and oncology products in the FDA’s CDER and director of the FDA’s Oncology Center of Excellence.
Following the same pathway, Loxo Oncology reported data with larotrectinib (LOXO-101), a tropomyosin receptor kinase (TRK) biomarker-specific drug, which could treat an array of cancer in various sites of the body. Loxo Oncology already showed a number of cases where children and adults with TRK fusion cancer responded to the larotrectinib
IBM introduced new data showing its Watson supercomputer agreed with doctors on a treatment course for a range of cancers up to 96% of the time.
BIO International Convention on June 19-22 in San Diego (USA)
5thAntibody Industrial Symposium, on June 27-28, in Tours (France)
MedFIT on June 28-29 in Grenoble (France)
Nordic Life Science Days (NLS) 2017 on September 12-14 in Malmö-Copenhagen (Sweden and Denmark)
BIOPharm America on September 26-27 in Boston (USA)
BIO Latin America on October 26-28 in Sao Paulo (Brazil)
BIO Europe on November 6-8 in Berlin (Germany)
World Congress on Biomedical Engineering 2017 on November 9-11 in Xian (China)
BIOFIT on November 28-29 in Strasbourg (France)
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