Biotech Analysis Central Pharma News: AbbVie's Trouble, Merck KGaA's Bad Streak, Puma's Positive Data

by: Terry Chrisomalis

AbbVie and Roche have trouble with Venclexta as partial clinical hold is placed.

Merck KGaA And Pfizer suffer a bad luck streak after latest Bavencio trial Failure.

Puma Biotechnology announces positive results from cervical cancer study.

Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.

AbbVie And Roche Have Trouble With Venclexta As Partial Clinical Hold Is Placed

News: Recently, AbbVie (ABBV) and Roche (OTCQX:RHHBY) announced that the FDA had placed a partial clinical hold on Venclexta in all clinical trials dealing with treating patients with blood cancer known as multiple myeloma (MM). Specifically, the reason for the partial clinical hold is because of the data that was looked at from a Phase 3 study known as the BELLINI trial or M14-031. It was noted that a larger portion of relapsed/refractory MM patients treated with the drug had a higher rate of death, compared to those on the control arm of the study. This prompted the FDA to immediately put a partial hold on all the multiple myeloma studies that are ongoing for Venetoclax.

Analysis: In my opinion, this is a slight setback. That's because this partial clinical hold only deals with the halting of recruitment of new patients, however, it won't stop ongoing treatment for those who have already entered the study. In addition, this doesn't affect Venetoclax for the indications it has already been approved for on the market. It has already been approved by the FDA to treat other types of blood cancer. The indications that Venetoclax is approved for are acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL).

It is uncertain whether or not the trial will eventually resume. However, that can't be determined until the final data is released in the coming months. From there, both AbbVie and Roche can assess whether or not they will continue to use Venetoclax to treat MM. Even then, I don't believe the drug will be in peril because the other indications have not yet been affected.

Merck KGaA And Pfizer Suffer A Bad Luck Streak After Latest Bavencio Trial Failure

News: Recently, Merck KGaA (OTCPK:MKKGY) and Pfizer (PFE) announced that they had failed to succeed in a phase 3 study in treating front-line patients with ovarian cancer. Specifically, this entails the Phase 3 JAVELIN Ovarian PARP 100 study. This study first treated patients with Bavencio in combination with chemotherapy. That was then followed with maintenance therapy of Bavencio in combination with talazoparib. It was noted by both companies that the amount of benefit observed for these ovarian cancer patients was not significant enough to continue the study. Based on the evaluation of interim data, it was chosen that the trial should be discontinued.

Analysis: In my opinion, this is bad news for Merck KGaA and Pfizer in that they can't go after the front-line ovarian cancer population. It's even worse news for patients that need an immuno-oncology treatment that targets this disease. Even if the Phase 3 study was a success, Bavencio would have faced competition with another strong ovarian cancer drug by the name of Lynparza. Lynparza has been approved and marketed by AstraZeneca (AZN) for several ovarian cancer indications.

It was a long-shot for two reasons anyways. The first reason is that it was in front-line ovarian cancer patients who were stage III or stage IV. Then, there is the issue of severe other prior failures in ovarian cancer. This latest study was their 3rd study to fail in ovarian cancer. I think the odds were already stacked against it to begin with. However, both companies are in good shape. This was just one cancer indication. Bavencio is still being explored in many other cancer studies.

The JAVELIN clinical program is evaluating at least 30 programs, which is spread out to more than 15 different tumor types that are being targeted. I believe that despite this setback in ovarian cancer, Bavencio still has a chance to succeed in other areas.

Puma Biotechnology Announces Positive Results From Cervical Cancer Study

News: Recently, Puma Biotechnology (PBYI) announced that it had achieved positive results from its Phase 2 SUMMIT trial. Specifically, this study treated patients with HER2-mutant metastatic cervical cancer. Patients were treated with daily treatment of NERLYNX (neratinib). It was an open-label type of a study, therefore, no placebo comparator was incorporated into it. The patients recruited into the study had taken a median of 2 prior regimens before entering.

Analysis: I feel that the positive data puts a solid spotlight on NERLYNX in treating HER-2 mutant metastatic cervical cancer. The objective response rate for the study was at 27.3%. The median progression-free survival rate of the patients was 7 months. The most notable item is the clinical benefit rate at 54.5%. The reason why I state that is because 3 patients had a partial response, and then another 3 had stable disease which lasted longer than 16 weeks.

Why is that impressive? Not only did these patients already go through a median of 2 treatments, but they also had advanced/metastatic disease to begin with. These patients were in dire situation even before entering the study. In my opinion, that's what makes the results that much more impressive. Not only that, but the drug was shown to be safe. The most notable adverse event was diarrhea. However, none of the adverse events forced the biotech to shift its dosing around for the study or for a patient to drop out. I believe that this program is in good shape moving forward.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.