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发帖数: 709 | 1 Dynavax Combo Therapy Shows Response Rates of 70% in Melanoma
2018-06-04 18:15:00.0 GMT
By Cristin Flanagan
(Bloomberg) -- Dynavax’s SD-101 in combination with Merck & Co.’s
Keytruda showed an overall response rate (ORR) of 70%, or 21 out of 30
melanoma patients, at SD-101 doses less than or equal to 2mg. Results
excluded seven patients on study who had not yet had an imaging scan.
* 2mg has been selected as the dose of SD-101 to be tested in late-stage
melanoma setting
* An 8mg dose of SD-101 showed an ORR of 38%, or 15 out of 39 patients; one
patient in this arm died, but death wasn’t considered treatment related
* NOTE: DVAX shares fell 14% on May 17 when earlier results released ahead
of the American Society of Clinical Oncology meeting showed ORR of 60%, or
15 out of 25 patients; RBC said ORR could have been 50% if non-evaluable
patients had been counted
* Side effects related to SD-101 in the latest data were manageable and
transient and there was no increase in immune related side effects beyond
what would be expected from Keytruda alone; SD-101 and Keytruda combination
appears much less toxic than Bristol-Myers Squibb’s Opdivo and Yervoy,
according to poster being presented at ASCO meeting
* JPMorgan analyst Anupam Rama said in note before today’s results that 50%
-60% ORR “is an appropriate benchmark” for initial Phase 2 results; Rama
also watching response rate for the dose selected for Phase 3 testing
To contact the reporter on this story:
Cristin Flanagan in New York at [email protected] To contact the
editors responsible for this story:
Catherine Larkin at [email protected] Brad Olesen | g******t
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