Dramatic Leap in Patient Demand for NHL Trials

With multiple drugs entering Phase III clinical trials in 2011, demand for patient enrollment in non-Hodgkin Lymphoma studies is skyrocketing. As shown in the table below, these trials include two Phase III efforts for GA101, which Roche is developing to combat the potential loss of exclusivity on current standard-of-care Rituxan in 2015; a subcutaneous version of Rituxan is also moving into Phase III trials this year. Considering both the importance of Rituxan to the Roche’s bottom line and the company’s presence in the field, one can expect highly competitive recruitment efforts for these trials. Though not shown in the table, several other products including Calistoga Pharmaceutical’s CAL-101 and Pharmacyclic’s PCI-32765 are at earlier stages of development but have generated considerable interest with new mechanisms of action in orally available form.

Drug

Company

NHL Type(s)

Regimen / Comparison

Primary Endpoint(s)

Enrollment

GA101

Roche / Genentech

Indolent, Advanced

GA101-Chemo v. Ritux-Chemo, followed by GA101 v. Ritux maintenance

PFS

1400

GA101

Roche / Genentech

DLBCL

GA101-CHOP v. Ritux-CHOP

PFS

1400

Bortezomib

Takeda-Millennium

DLBCL

Bortezomib-CHOP v. Ritux-CHOP

PFS

940

Bendamustine

Cephalon

Indolent

Bendamustine v. Investigator's Choice

PFS

125

Inotuzumab

Pfizer

DLBCL

Inotuzumab-Ritux v. Investigator's Choice

OS

377

Pixantrone

Cell Therapeutics

DLBCL

Pixantrone-Ritux v. Gemcitabine-Ritux

PFS, OS

350

Rituximab (Subcutaneous)

Roche / Genentech

Follicular

Sub-Q Ritux v. IV Ritux

PK, Response, PFS

530

All this activity will put strains on clinical trial enrollment goals for the foreseeable future. Indeed, VOI Consulting’s analysis shows that an average of 3,160 newly randomized patients will be needed in both 2012 and 2013 to fully enroll all industry-sponsored Phase II/Phase III studies trials in B-cell NHL alone. This represents a 68% increase in patient demand compared to the 2007-2010 average and does not include trials that have yet to be registered.

Data from VOI’s insiteinvestigator shows that major NHL drug trials have accrued at a little under 0.16 patients per site per month in recent years. At this rate, it will require approximately 19,750 “site months” to meet currently scheduled enrollment needs for 2012; a target that would require the industry to enlist a total of 1,645 sites worldwide within the 12-month period. Leaving aside the fact that competition will decrease average site productivity levels, this number is significantly higher than currently available infrastructure.

Now consider that at least the same number of patients will be required in 2013 and it becomes pretty clear that NHL trials are going to experience major delays. Companies in this space should be prepared for stiff competition and plan recruitment efforts and site lists accordingly.


Donald Clark
Donald Clark

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