Last week I had the opportunity to interview the Senior Director of Clinical Research for Janssen Pharmaceuticals, Dr. Tahamtan Ahmadi, PhD. Janssen is the company that manufacturers newly FDA approved Darzalex (daratumumab). I promised a more detailed follow up and I’m glad to follow through.

Here’s a link to the original post:

Big news about daratumumab today

Posted on December 07 2015 | 1,008 views

This excerpt helps set things up:

Dr. Ahmadi spearheaded the recent push for early FDA approval of the exciting new immunotherapy drug, Darzalex (daratumumab).

I’m preparing several posts featuring Dr. Ahmadi and his work. Young, enthusiastic and incredibly bright, Dr. Ahmadi gave me a heads up about this morning’s news, embargoed for a few more hours.

While I can’t share specifics yet, I can pass along that results from a pair of clinical trials will reveal an amazing response rate in heavily pretreated patients when using daratumumab in combination with several established novel myeloma therapy agents.

Even more impressive and unexpected: a length and depth of response that had Dr. Ahmadi so excited I thought he was going to leap up off the grey curved couch outside the ASH press room…

Ahmadi-Tahamtan

Some of what Dr. Ahmidi shared was off the record. It dealt with a number of ongoing clinical trials worldwide. Here’s what I can share with you:

Janssen is taking a world view with daratumumab. Recognizing that different therapy regimens are commonly used in different regions, Janssen is funding five Phase 3 studies featuring daratumumab in combinations with therapies like melphalan/prednisone and daratumumab/thalidomide.

Dr. Ahmadi took me back to January, 2014, stressing what a huge risk it was to gamble on what turned out to be an exceptionally small data set. I didn’t realize what a complicated process it was to manufacture a monoclonal antibody. It is small batch, individualized process. So creating enough to use in the expedited clinical trials during the compressed, two year approval process was daunting.

Dr. Ahmadi described the FDA as “a helpful collaborator,” assisting the company to achieve the fastest possible launch. He should know: Dr. Ahmadi was the go-between for Janssen and FDA investigators.

He spoke glowingly of the FDA’s work to try and expedite the process. I suggested someone in government should get some credit once in a while; considering budget cuts, I found it impressive that the FDA “got it,” and proved to be so nimble. Dr. Ahmadi agreed.

But most of the conversation centered on the depth of response that Darzalex was producing, some in trials that have yet to report their data.

I found reasons to be both excited and skeptical when preliminary data combining Darzalex with Revlimid and Pomalyst on Monday after I discovered that patients that populated the trials to not be very heavily pretreated. But based on my interview with Dr. Ahmadi, we’re not to worry. He feels combo data will also be impressive in patient groups that have been exposed to more prior therapies.

I found Dr. Ahmadi to be incredibly bright and enthusiastic. My impression was that he genuinely cares about patients, and is reassured by the fact that side effects caused by Darzalex are for the most part manageable–and that the drug tends to be easier to tolerate than other FDA approved myeloma therapies.

Good guy! So were the half dozen Janssen team members I met.

And don’t forget that there is a lot of anecdotal evidence about the effectiveness of Darzalex as a single agent. Remember this post?

Reader celebrating great response to daratumumab

Posted on October 14 2015 by Pat Killingsworth | 3,185 views

The patient from my post, Mike, recently emailed me again, excited that his monthly reports continue to show success against his heavily pretreated myeloma. Isn’t that wonderful? Here’s hoping all of Dr. Ahmadi and the Janssen’s hard work pays off for a lot more of us.

Feel good and keep smiling! Pat