Roche’s Phase 3 Study GOYA Fails- Swiss drug maker Roche (RHHBY) announced that a Phase 3 clinical trial evaluating its Gazyva/Gazyvaro (obinutuzumab) plus CHOP chemotherapy in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL) failed to meet its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to MabThera/Rituxan (rituximab) plus CHOP chemo. The company will present the full results from the failed trial at future medical conference. The drug is currently approved in the U.S. for the treatment of chronic lymphocytic leukemia and follicular lymphoma, both in combination with certain types of chemo.
AstraZeneca’s TAGRISSO Succeeds in Late-Stage Study- British drug maker AstraZeneca (AZN) announced that a Phase 3 clinical trial called AURA3, evaluating its TAGRISSO (osimertinib) as second-line treatment in patients with EGFR T790M mutation-positive, locally advanced and metastatic non-small cell lung cancer (NSCLC) met its primary endpoint of a statistically valid increase in progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The treatment group also showed clinically meaningful increases in objective response rate, disease control rate and duration of response. Complete data will be presented at an upcoming medical conference. TAGRISSO has already been approved by the FDA for the treatment of EGFR T790M-positive NSCLC that has progressed after EGFR-blocking therapy. Under accelerated review, continued approval may be contingent on further confirmatory studies.
ViiV Healthcare Presents 48-Week Data from ARIA Study- ViiV Healthcare presented 48-week data from the Phase IIIb, open-label, international, multi-center ARIA study which showed superior efficacy for Triumeq (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. Results showed statistically superior viral suppression (HIV-1 RNA <50 c/mL) rates at week 48: 82% versus 71% (adjusted difference 10.5%, 95% CI: 3.1%-17.8%, p=0.005) respectively. ARIA was a non-inferiority study with a pre-specified analysis for superiority. Both endpoints were met. ViiV Healthcare is a joint venture between GlaxoSmithKline (GSK) and Pfizer (PFE).
Brainstorm Announces Data from Mid-Stage Study of NurOwn- Brainstorm Cell Therapeutics (BCLI) announced data from a Phase 2 study evaluating NurOwn mesenchymal stem cells for the treatment of patients with amyotrophic lateral sclerosis (ALS). Treatment with NurOwn consistently beat placebo, although the difference at most time points (2 weeks - 24 weeks) fell short of statistical significance. Also the treatment effect rapidly diminished over time. The company plans to meet with the FDA to discuss the results. A larger confirmatory study is the next step. BCLI shares dropped more than 9% on Monday but have bounced back in pre-market trading today.
pSivida Announces R&D Consolidation Plan- pSivida (PSDV) announced that it is implementing a site consolidation plan whereby all of its R&D and product development will be conducted at a single location. It intends to close its Malvern, U.K. site and locate all of the functions at its Watertown, Massachusetts facility. The company expects the move to save $900K a year in pre-tax operating expenses starting in the fourth quarter. It will book $680K in charges related to the plan.
Dr. Reddy’s Launches ZEGERID Generic- Indian drug maker Dr. Reddy’s Laboratories (RDY) announced the launch of n FDA-approved Omeprazole and Sodium bicarbonate capsules, 20mg/1100mg and 40mg/1100mg, a therapeutic equivalent generic version of ZEGERID (omeprazole/sodium bicarbonate) capsules in the U.S. According to IMS Health, the Zegerid brand and generic had U.S. sales of ~$307M for the 12-month period ending May 2016.