re: GERN
jq1234,
I think you're missing the point. Here is Dr. Tefferi's comments in Blood:
Abstract
The current document is a revision of the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria for treatment response in myelofibrosis (MF) and represents a collaborative effort by the IWG-MRT and the European LeukemiaNet to objectively assess the value of new drugs in inducing morphologic remission or improvement in MF-associated symptomatic burden (MF-SB). Some of the changes in the current revision include stricter definitions of red cell transfusion dependency and independency and consideration of the Myeloproliferative Neoplasm Symptom Assessment Form as a tool to quantify meaningful changes in disease-related symptoms. Six response categories are listed: complete remission (CR) and partial remission signify treatment effects that are consistent with disease modification, whereas drug-induced improvements in MF-SB were annotated as clinical improvement, anemia response, spleen response, or symptoms response. Additional criteria are provided for progressive disease, stable disease, and relapse. The document also includes recommendations for assessing cytogenetic and molecular remissions, without mandating their inclusion for CR assignment...
A plethora of new drugs, including thalidomide analogs10 and Janus kinase11?-13 or mammalian target of rapamycin14 inhibitors, have been recently developed and evaluated in MF clinical trials. So far, none of these new drugs have displayed selective anti-clonal effect, despite an otherwise remarkable activity in alleviating anemia, splenic discomfort, and constitutional symptoms. In other words, the value of such drugs would be undermined if formal response criteria in MF did not include response categories that capture drug benefit in terms of MF-SB, which impacts health-related QoL. However, there is no good evidence to indicate that responses in anemia, splenomegaly, or symptoms could be used as surrogates for improved survival. Consensus-based definitions of response, in this regard, are designed for the purpose of standardizing response criteria for use in clinical trials and not for use in routine care of patients.
The IWG-MRT and ELN response categories other than CR and PR were developed in recognition of the profound impact of MF-SB to health-related QoL. The primary contributors of decreased health-related QoL in MF are anemia, marked splenomegaly, and constitutional symptoms. Accordingly, the current revised document includes response definitions for each one of these specific disease features and an additional composite response category, labeled as clinical improvement (CI), and defined as a response in anemia, splenomegaly, or MF-SB that is not associated with progressive splenomegaly (Table 1) or increase in severity of anemia, thrombocytopenia, or neutropenia (Table 1 footnotes). Accordingly, an anemia response that might be associated with progressive splenomegaly (as has been seen with pomalidomide therapy)20 or spleen response associated with drug-induced anemia (as has been seen with some Janus kinase inhibitors),11,21 would still be included in an individual response category, although not counted as CI. Similarly, for a symptom response to count as CI, it requires the absence of progressive splenomegaly and treatment-associated anemia.
In other words, there may well have been clinical responses that were not counted as CI. And we know from the abstract part that you quoted (although not your highlighted part) that there were three patients with clinical improvement, which "requires the absence of progressive splenomegaly and treatment-associated anemia," but there could, and probably were, given the overall response rate, patients that showed clinical improvement, but did not meet the rigid requirements that Dr. Tefferi et. al. have established for a CI.
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