Avid Bioservices Inc (CDMO)

[nuke661]

lorekarf,

I posted a response to lame attempt at a listing of NSCLC drugs that any one of them were, in that poster's opinion, better than Bavi for NSCLC.

One of them was BMS's PD-1 drug BMS-936558. Here is on of the links for trial data on that drug:
http://www.hematologyandoncology.net/index.php/supplements/highlights-in-nsclc-from-the-2012-chicago-multidisciplinary-symposium-in-thoracic-oncology/

My read of the data for the BMS drug and Bavi's data were almost on equal footing. One thing to note is they (BMS) had 120 patients enter their trials and Bavi only had 41 (the handicaps of being a poor small cap biotech). It should also be noted how many of those 120 BMS trial patients made it to being evaluable; 76. Not a whole lot of difference there IMO between the Bavi and BMS PD-1 drug trials - percentage wise - though slightly in BMS favor.


A favorable item on the BMS side is that they included Squamous cell patients and had a 33% ORR for them. But on the negative side for them (especially when comparing directly to Bavi's trial data), only had a 12.5 % ORR for the non-squamous population - advantage to Bavi at 17 % (if not handicapping the smaller Bavi trial size; which I'm sure the professional anti-Bavi crowd will be wont to do).

There was only PFS data to 24 weeks for BMS. Bavi has long term survival data to 29 months. I don't know enough of the Bavi data makeup (such as how many are actually alive at 29 months) to outright declare that a ringing advantage for Bavi but in comparison it certainly appears to be a big unknown for BMS's drug; especially if trying to use ORR as a surrogate for long term survival. We actually have a 29 month plateau, what do they have?

Bavituximab, the Rodney Dangerfield of Biotech.

I see the link doesn't take you directly to the article. Here is the info I extracted (you can create an account for free and access the article):

Clinical Activity and Safety of Anti-PD-1 (BMS-936558, MDX-1106) in Patients (Pts) With Advanced Non-Small-Cell Lung Cancer (NSCLC)
The safety population of 120 new patients had a mean age of 65 years, and most were men (61%). Patients were divided between squamous cell histology (39%) and nonsquamous cell histology (60%). Most patients had good ECOG PS (0 for 34 patients, 1 for 83 patients, 2 for 2 patients, and not reported for 3 patients). The number of prior therapies was 1 for 18 patients, 2 for 31 patients, 3 for 27 patients, and 4 or more for 40 patients. Platinum-based therapies had been administered in 94% of patients, and 34% had received a prior tyrosine kinase inhibitor.
BMS-936558 was generally well tolerated. AEs occurred in 64% of NSCLC patients. The maximum tolerated dose was not found. At the doses of up to 10 mg/kg included in this study, no relationship was apparent between dose and AE frequency. In the NSCLC patients, the common drug-related AEs were fatigue (18%), decreased appetite (10%), anemia (8%), nausea (7%), pyrexia (6%), and diarrhea (6%). Such events were consistent with the immunogenic activity of BMS-936558. Grade 3–5 related AEs occurred in 8% of the NSCLC patients. In patients with NSCLC, fatigue was the most common grade 3/4 toxicity (2% of patients). Grade 1/2 pneumonitis occurred in 6 (2%) patients, including 4 (3%) NSCLC patients. Among the patients with pneumonitis, 3 drug-related deaths occurred (2 patients with NSCLC and 1 with colorectal cancer).
Among the 76 patients with NSCLC who were evaluable for clinical activity, the ORR was 18% (Table 2). There were 14 cases of PR, which occurred at doses of 1 (1 of 18 patients), 3 (6 of 19 patients), and 10 mg/kg (7 of 39 patients), resulting in response rates of 6%, 32%, and 18%, respectively. Two additional NSCLC patients who had received the antibody at a dose of 10 mg/kg were awaiting a confirmatory scan, and thus had unconfirmed PRs.
The anti-PD-1 antibody was active in both squamous and nonsquamous NSCLC histologies. Responses occurred in 6 of the 18 patients with squamous histology (33%) and in 7 of the 56 patients with nonsquamous histology (12.5%). All 14 of the responding patients began treatment more than 24 weeks before the analysis, and 8 of these patients had a response that lasted 24 weeks or longer. Further, 3 patients had a persistent decrease in overall tumor burden in the presence of new lesions, so they were not classified as responders.
BMS-936558 can be administered safely in heavily pretreated NSCLC patients in an outpatient setting. BMS-936558 is well tolerated. The clinical activity of BMS-936558 in patients with previously treated, advanced NSCLC is encouraging and warrants further development of this agent in patients with advanced NSCLC.