Monday, April 20, 2015

Will Roche/Genetech Pivot Hard, Drive The Lane -- And Snag "First Mover" Anti-PD1L Rights In Certain Breast Cancer(s), This Fall?

To be sure, Merck's three pieces of monoclonal antibody Anti-PD1L good news created quite the buzz at AACR, yesterday afternoon. I do still believe that BMS's Opdivo® has the lead in all cancers, for at least the next 12 months. I'll explain why, at the bottom of this post.

In the mean time, though -- there is some very exciting news for Roche. It seems that Roche's early results with its MPDL3280A, also a PD1L monoclonal antibody (like Merck's) -- in breast cancer -- will allow Roche to take its breakthrough designation straight to an approval filing at FDA as early as this summer. So, will Roche be able to crash the lane, and lay one in (or even throw down a dunk?!) in some of the most aggresive breast cancers, effectively "posterizing" both Merck and BMS -- for at least this $5 billion segment? We shall have to watch and see. Here is the latest Bloomberg note on it all -- do go read it:

. . . .In an early-stage trial of people with an aggressive form of breast cancer who took the experimental Roche drug called MPDL3280A, tumors shrank in four of 21 patients, with cancer disappearing in two cases, according to findings announced Monday at an oncology meeting in Philadelphia. . . . While Merck and Bristol have already won regulatory approval for immunotherapies -- Keytruda for melanoma in Merck’s case and Opdivo for melanoma and lung cancer in Bristol’s -- Roche has a strong track record in cancer research and development that “may translate into commercial differentiation,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. . . .

About 15 percent of breast-cancer patients have the triple-negative type studied in the trial. In that form of the disease, tumor cells don’t have estrogen and progesterone receptors, and lack extra HER2 proteins. MPDL3280A would be used along with chemotherapy, which is now the primary treatment option. . . .

Even so, as I said at the top, BMS is the one to beat. I am increasingly hearing from oncologists at teaching hospitals that a few government programs are agreeing to cover so called "off-label" use of nivolumab.

It is that good -- and it is being used, right now, to fight a wide array of cancers, in clinics all over the nation. While the government payers (Medicare/Medicaid) aren't reimbursing at full retail rates, for the off-label cancers, the trend is in the right direction. I wonder how long it will be before private insurers will no longer be able to resist coverage for these revolutionary agents -- even prior to full FDA approval of them for -- say end stage kidney, liver or breast cancer.

I think the field is wide open, but BMS's Opdivo has the clearest lane to the hoop, and victory now. Merck had better get its specialist detailers in gear, and offer the oncologists the recent evidence that reimbursement is happening, even off-label. That would be very good for Kenilworth's Keytruda® ramp up, here in the latter parts of 2015. [Ed. note: fair use, and transformative/derivative use claimed (under applicable US common law) for Jill Laufer's fine CGI (a video, from which that single antibody still was derived, in my image), all on the Roche candidate called MPDL3280A, above.]

As ever, we shall watch and see.


Anonymous said...

Keytruda is an anti-PD-1 mAB, like Opdivo, not an anti-PD-L1 mAB.

Anonymous said...

BMY and MRK have melanoma sewn up and will likely do the same in lung cancer (although others will want to get piece of the lung cancer pie as it is so big). Roche and AZN have already announced their intentions to go after other tumor types to beat BMY and MRK.