03:21 , Nov 17, 2018 |  BioCentury  |  Product Development

Betting Combos on Biomarkers

Despite lackluster monotherapy data at SITC from the latest tranche of immunotherapy candidates, drug developers are moving into combination trials with PD-1 and PD-L1 inhibitors based on biomarkers of pharmacodynamic activity. Results from the next...
22:19 , Nov 16, 2018 |  BC Extra  |  Company News

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup. The agency backed...
20:42 , Nov 16, 2018 |  BC Extra  |  Clinical News

Imfinzi fails again in MYSTIC trial for first-line NSCLC

In another strike against tremelimumab, AstraZeneca plc (LSE:AZN; NYSE:AZN) said the anti-CTLA-4 mAb in combination with PD-L1 inhibitor Imfinzi durvalumab missed the co-primary endpoint of improving overall survival (OS) in the Phase III MYSTIC trial...
16:02 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Nektar makes case for NKTR-214 optimism

On a Nov. 10 call with investors, Nektar Therapeutics (NASDAQ:NKTR) and a PI for the Phase I/II PIVOT-2 trial highlighted differences in patient demographics that could be critical for NKTR-214 plus Opdivo nivolumab to achieve...
15:53 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Fecal transplant could treat toxicity common to checkpoint inhibitors

University of Texas MD Anderson Cancer Center researchers used fecal transplants to treat refractory immune checkpoint inhibitor-associated colitis in cancer patients. Colitis is one of the most common toxicities associated with checkpoint inhibitor immunotherapy, occurring...
20:43 , Nov 12, 2018 |  BC Extra  |  Clinical News

Fecal transplant could treat toxicity common to checkpoint inhibitors

University of Texas MD Anderson Cancer Center researchers used fecal transplants to treat refractory immune checkpoint inhibitor-associated colitis in cancer patients. Colitis is one of the most common toxicities associated with checkpoint inhibitor immunotherapy, occurring...
01:02 , Nov 10, 2018 |  BC Extra  |  Clinical News

NKTR-214 CR data at SITC suggest advantage over SOC

Updated Phase I/II data presented Friday for NKTR-214 from Nektar Therapeutics (NASDAQ:NKTR) plus Opdivo nivolumab to treat previously untreated patients with metastatic stage IV melanoma showed an objective response rate (ORR) that included more patients...
21:13 , Nov 6, 2018 |  BC Extra  |  Clinical News

Nektar shares fall on updated response data for NKTR-214 combo

Nektar Therapeutics (NASDAQ:NKTR) was off $3.92 (10%) to $36.08 on Tuesday as investors digested updated response data released in an abstract ahead of this week's SITC meeting from a Phase I/II trial of NKTR-214 plus...
18:57 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said on Oct. 19 that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The...
16:47 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

Latest immuno-oncology monotherapy data continue to cast doubt on combo strategies

New data for next generation immuno-oncology agents add to the debate of whether and how agents that show no efficacy as monotherapies in Phase I trials should be advanced to later stage combination trials. Merck...