Replies to post #4368 on Halozyme Therapeutics Inc (HALO)

[friendofthedevil]

I guess so. Remember that HR = 1.0 means the two groups have no difference. The lower the HR, the more separation there is between groups.

Regardless of the HR, I would be cautious in making too much from the stage 1 Ph2 efficacy data. The best thing we know from the 202 trial so far is that LMWH makes it safe to run the 301 trial.

I have been critical in the past of the strength of the stage 1 efficacy data. The large number of subjects with HA status that is undetermined, the 'meh' OS data, as well as the increase in the HR when a hand picked sub group was tested with the new HA method all undermines my faith in the trial data (so far). I am eagerly awaiting 202 data in the fall. At least the PFS should be available and I will look it over closely.

The overall biotech market has been brutal this year and I'm not sure biotech will get out of this funk in 2016. I hope I'm wrong. But any company that might have to raise in the near term could have issues with dilution. The $150 million raise HALO did was brilliant but the rate at which they are spending it was disappointing. Because of this, I have since cut back on my overweight investment here to represent a more average share of my portfolio. I will be watching the balance sheet as well as the PEG results to see if or when I will increase exposure.

[rod5247]

This excerpt may help you and reading the entire article is well worth the time.

Initial Therapy

Tempero's presentation focused on choosing regimens for initial therapy for patients with metastatic disease. In reviewing the recent history, she called FOLFIRINOX (folinic acid [leucovorin], fluorouracil [5FU], irinotecan, oxaliplatin) a breakthrough in treatment as shown in the randomized PRODIGE 4/ACCORD 11 trial (Conroy et al: NEJM 2011;364:1817-1825). That trial compared FOLFIRINOX with gemcitabine monotherapy for patients with high performance status, and the results led to the adoption of FOLFIRINOX as a front-line standard.



“The results were nothing less than dramatic--an improvement in overall survival, with a hazard ratio of 0.57. That's a hazard ratio we would like to see in every trial that we do.”



Still, that improvement comes at some cost: “It's a tough regimen, with dominating toxicities of myelosuppression, diarrhea, and neuropathy. We are getting better at making FOLFIRINOX more tolerable by omitting the bolus 5FU, reducing doses, and using chemotherapy holidays. We're still figuring it out, and as more trials are done with FOLFIRINOX-like regimens we will finally settle into a regimen that is more tolerable.”



Nab-Paclitaxel

The next contender for standard treatment was nab-paclitaxel, as demonstrated in a trial of that plus gemcitabine versus gemcitabine alone (Von Hoff et al: NEJM 2013:309:1691-1703).



“The overall survival benefit was not as dramatic as with FOLFIRINOX, but it had a respectable hazard ratio of 0.72,” Tempero said. “A clinically meaningful hazard ratio of anything less than 0.75 has to be taken very seriously.”



But nab-paclitaxel plus gemcitabine is also not an easy regimen to take--“perhaps easier to manage than FOLFIRINOX but not a walk in the park.”

http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=1308&desktopMode=true