Wed, Nov. 25, 9:50 AM
- As expected, the European Commission approves Roche's (OTCQX:RHHBY +1.5%) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of adults with unresectable or metastatic BRAF V600 mutation-positive melanoma.
- Cobimetinib, co-developed with discoverer Exelixis (EXEL +1.1%), inhibits an enzyme called mitogen-activated protein kinase kinase (MEK), a mediator of downstream signaling of tumor growth factor receptors. Vemurafenib is a BRAF inhibitor that was discovered by Daiichi Sankyo's (OTCPK:DSKYF)(OTCPK:DSNKY) Plexxikon unit.
- Previously: European Ad Comm gives thumbs up to Roche's Cotellic/Zelboraf combo for certain type of melanoma (Sept. 25)
Mon, Nov. 23, 7:23 AM
- Results from a Phase 1b study show Roche's (OTCQX:RHHBY) investigational cancer immunotherapy candidate atezolizumab (MPDL3280A), in combination with Zelboraf (vemurafenib), produced a significant treatment effect in patients with previously untreated BRAF-positive unresectable or metastatic melanoma. In 17 patients, the objective response rate was 76% (n=13/17), including three complete responders. The data were presented at the Society of Melanoma Research 2015 International Congress in San Francisco.
- Objective response rate includes complete responders, partial responders and those with stable disease (progression-free).
- No dose-limiting toxicities or atezolizumab-related treatment discontinuations were observed, although staggering the dosing of atezolizumab and Zelboraf after Zelboraf run-in was better tolerated that concurrent dosing. The incidence of Grade 3 (severe) adverse events (AEs) related to atezolizumab and Zelboraf was 41% and 59%, respectively. Treatment-related AEs included pyrexia (high fever) and dehydration.
- Atezolizumab is a PD-L1 inhibitor while vemurafenib is a kinase inhibitor.
- The company's development of the combination is ongoing.
Thu, Nov. 19, 11:42 AM
- An analysis of completed clinical trials showed patients with recurrent glioblastoma multiforme (rGBM), the most common form of malignant brain tumor, treated with VBL Therapeutics' (VBLT -0.2%) lead oncology candidate, Fast Track- and Orphan Drug-tagged VB-111, experienced a significant jump in survival compared to Roche's (OTCQX:RHHBY +0.1%) Avastin (bevacizumab). The data will be presented tomorrow at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology in San Antonio, TX.
- The data compared the 12-month overall survival achieved with VB-111 in a mid-stage study in rGBM to the results from four studies of bevacizumab in rGBM (n=233). Results from a recent Phase 2 trial showed patients treated with VB-111, in combination with bevacizumab upon disease progression, demonstrated a survival rate of 57% at month 12, more than double the overall 28% survival rate at month 12 seen in the four bevacizumab-only trials (range: 16% - 38%).
- Patient recruitment is underway in a Phase 3 study, GLOBE, comparing VB-111 in combination with Avastin to Avastin alone in rGMB. Interim results should be available in Q1 2017. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2017.
Tue, Nov. 17, 7:06 AM
- Roche's (OTCQX:RHHBY) Genentech unit exercises its option to participate in the financial arrangements related to Novartis' (NYSE:NVS) rights under its ex-U.S. agreement with Ophthotech (NASDAQ:OPHT) for Fovista (pegpleranib) for the treatment of wet age-related macular degeneration (wet AMD). Roche's option originates from a pre-existing agreement with Novartis. Specific financial terms are not disclosed.
- Ophthotech's deal with Novartis, inked in May 2014, remains in effect. Ophthotech retains exclusive rights to Fovista in the U.S. while Novartis owns exclusive rights ex-U.S. Ophthotech has the potential to earn more than $1B in upfront and milestone payments during the course of the collaboration.
- Last month, patient recruitment was completed in a Phase 3 clinical trial assessing the combination of Fovista and Roche's Lucentis (ranibizumab) in wet AMD. Top line data should be available in Q4 2016.
- Previously: Ophthotech completes enrollment in second late-state study of Fovista in wet AMD (Oct. 26)
- Previously: Novartis acquires rights to ophthalmic drug (May 19, 2014)
- Previously: More on Novartis/Ophthotech commercialization deal (May 20, 2014)
Mon, Nov. 16, 11:43 AM
- Based on the recommendation from the independent Data Monitoring Committee, a Phase 3 clinical trial, Study 115, evaluating Gilead Sciences' (GILD -0.7%) Zydelig (idelalisib) added to standard therapy in patients with relapsed chronic lymphocytic leukemia (CLL) will be unblinded early based on a statistically significant benefit in progression-free survival compared to standard therapy alone. Full results will be presented at the American Society of Hematology Annual Meeting in Orlando, FL December 5-8.
- Study 115 is a 416-subject, double-blind, placebo-controlled trial. Participants were randomized 1:1 to receive six cycles of the chemo agent bendamustine and rituximab over 24 weeks combined with Zydelig 150 mg or placebo taken orally twice/day continuously until disease progression or unacceptable toxicity.
- Zydelig is approved in the U.S., in combination with Roche's (OTCQX:RHHBY -1%) Rituxan (rituximab), for the treatment of relapsed CLL. It inhibits a protein called phophoinositide 3-kinase (PI3K) delta which plays a key role in the activation, proliferation and survival of the immune system's B cells.
Fri, Nov. 13, 9:59 AM
- Under its accelerated review process, the FDA approves AstraZeneca's (AZN +0.6%) Breakthrough Therapy-, Priority Review- and Orphan Drug-tagged Tagrisso (osimertinib) for the treatment of patients with T790M+ non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with other EGFR-blocking therapies.
- In clinical studies, as many as 61% of T790M+ NSCLC patients treated with osimertinib (formerly AZD9291) experienced a complete or partial reduction in their tumor size.
- Concurrently, the FDA approves Roche's (OTCQX:RHHBY -0.8%) companion diagnostic test for T790M+ NSCLC for use in selecting patients for treatment with Tagrisso. It also detects NSCLC with exon 19 deletions or L858R mutations to select suitable patients for treatment with Tarceva (erlotinib).
Fri, Nov. 13, 8:33 AM
- Based on its analysis of unblinded trial data, the independent Data Monitoring Committee (DMC) recommends Merck's (NYSE:MRK) REVEAL outcomes study of anacetrapib continue with no changes. According to clinicaltrials.gov, the estimated completion date for the 30,000-subject trial is January 2017.
- Anacetrapib inhibits a protein called cholesterol ester transfer protein (CETP), which is designed to elevate HDL cholesterol (the "good" cholesterol). CETP inhibitors were all the rage a few years ago over their potential to provide more cardioprotective benefits than lowering LDL cholesterol (the "bad" cholesterol). Big Pharma's efforts to push CETP inhibitors over the finish line hit fell flat due to toxicity and less-than-expected efficacy. Eli Lilly (NYSE:LLY), Roche (OTCQX:RHHBY), and Pfizer (NYSE:PFE) all abandoned their programs.
- Merck has not given up, however. It ran a 1,623-subject study, DEFINE, which showed that anacetrapib was both safe and effective and raised HDL by 150%. REVEAL, initiated in 2011, is designed to settle the issue once and for all. The trial will cost upwards of $500M to complete so the company is banking on a positive outcome.
Thu, Nov. 12, 12:35 PM
- Citing excess manufacturing capacity precipitated by the evolution of its small molecule portfolio to lower-volume specialized medicines, Roche (OTCQX:RHHBY +0.8%) initiates plans to exit four manufacturing sites located in Clarecastle, Ireland, Leganes, Spain, Segrate, Italy and Florence, SC in the United States. In order to minimize job cuts, which could reach 1,200 if the sites are shuttered, it is actively seeking buyers for the facilities. The transition will begin in 2016 and is expected to conclude in 2021.
- The move, along with other efficiency efforts, will result in non-core structuring costs of 1.6B Swiss francs until 2021, CHF600M in cash.
- The company intends to invest CHF 300M in a dedicated facility in Kaiseraugst, Switzerland to manufacture specialized drugs.
Tue, Nov. 10, 11:37 AM
- The FDA approves Roche's (OTCQX:RHHBY -1.1%) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600E mutation-positive or V600K-positive metastatic or unresectable melanoma.
- Cobimetinib slows cancer cell growth by inhibiting an enzyme called MEK (Mitogen-activated protein kinase kinase) which plays a key role in activating melanoma. Restraining MEK signaling slows cancer cell proliferation and induces apoptosis (controlled cell death).
- Zelboraf was approved by the FDA in August 2011 for the treatment of advanced BRAF V600E+ melanoma.
- In clinical studies, patients receiving the combination experienced an average increase in progression-free survival of over five months (12.3 months vs. 7.2 months) compared to those patients treated with Zelboraf alone. Additional benefits of the combination were longer overall survival (65% of combo patients were alive 17 months after beginning treatment versus 50% for Zelboraf alone) and a greater proportion experiencing complete or partial shrinkage of their tumors (70% vs. 50%).
- According to the National Cancer Institute, almost 74K Americans will be diagnosed with melanoma this year and almost 10K will die from it.
- Previously: Roche's Cotellic + Zelboraf improves survival in melanoma patients vs Zelboraf alone (Oct. 6)
Thu, Nov. 5, 9:57 AM
- Roche (OTCQX:RHHBY +1.6%) updated investors today on its pipeline of products across a range diseases. Key points:
- Cotellic (cobimetinib) is currently under regulatory review in the U.S. and Europe for BRAF+ unresectable metastatic melanoma, in combination with Zelboraf (vemurafenib). Decisions from the FDA and EMA are expected in November and December, respectively.
- March 4, 2016 is the PDUFA date for the FDA's review of Breakthrough Therapy-tagged alectinib for ALK+ non-small cell lung cancer (NSCLC). The MAA was filed in Europe in September.
- Global regulatory applications are planned in early 2016 for ocrelizumab in primary progressive and relapsing forms of multiple sclerosis.
- Rolling NDA submission to the FDA underway for PD-L1 inhibitor atezolizumab (MPDL3280A) for certain types of metastatic bladder and lung cancer. Final data submission expected in Q1.
- First results expected in 2017 from several Phase 3 studies evaluating atezolizumab plus chemo in first-line NSCLC. Atezolizumab is also being evaluated in combination with a variety of targeted therapies across a range of cancers.
- Expanded label for Gazyva/Gazyvaro (obinutuzumab) currently under FDA review for follicular lymphoma. The sBLA was accepted under Priority Review in October.
- Venetoclax, a small molecule Bcl-2 inhibitor being co-developed with <<AbbVie>>, is currently in Phase 2 & 3 trials various blood cancers. Regulatory application completed by AbbVie to FDA for CLL with 17p deletion.
- Other near-term products are lebrikizumab for severe asthma, ACE910 for hemophilia A and lampalizumab geographic atrophy, an advanced form of age-related macular degeneration.
Thu, Oct. 29, 9:31 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a randomized Phase 2 clinical trial evaluating denintuzumab mafodotin (SGN-CD19A), in combination with the second-line salvage regimen of Roche's (OTCQX:RHHBY) Rituxan (rituximab), ifosfamide, carboplatin and etoposide (RICE), for the treatment of relapse/refractory diffuse large B-cell lymphoma (DLBCL). The 150-subject, open-label study will compare the combination regimen to RICE alone. The primary endpoint is the comparison of complete remission rates between the two treatment arms.
- Denintuzumab mafodotin is an antibody-drug conjugate (ADC) targeting CD19, a protein highly expressed on the surface of malignant B cells.
Mon, Oct. 26, 5:24 PM
- Ophthotech (NASDAQ:OPHT) hits its enrollment target in its second Phase 3 clinical trial evaluating Fast Track-tagged Fovista (pegleranib), in combination with Roche's (OTCQX:RHHBY) Lucentis (ranibizumab), for the treatment of wet age-related macular degeneration (wet AMD). Top-line data from both studies are expected in Q4 2016.
- CEO David Guyer, M.D., says, "Completion of patient recruitment in these two large scale Phase 3 clinical trials of [Fovista] in combination with Lucentis is a significant milestone in the Fovista Phase 3 pivotal program. We believe that Fovista, administered in combination with anti-VEGF therapy, may represent a significant advancement in the treatment of wet AMD and we look forward to obtaining data from both of these studies."
- A third Phase 3 study assessing Fovista in combination with either Regeneron (NASDAQ:REGN) and Bayer's (OTCPK:BAYRY) Eylea (aflibercept) or Roche's Avastin (bevacizumab) continues to enroll participants.
- Fovista is an anti-platelet-derived growth factor (anti-PDGF) agent.
- Previously: Ophthotech moving ahead with Fovista studies (May 11)
Sat, Oct. 24, 7:50 AM
- “We’re trying to figure out where we are and what we do going forward," a Walgreens Boots Alliance (NASDAQ:WBA) source tells the WSJ. "We need to understand the truth."
- The drugstore chain has "no concrete plans at this stage" to expand its partnership with Theranos beyond the 41 stores in Arizona and California which already include Theranos "wellness centers," reports the Journal. That partnership also includes an equity stake in the startup.
- Walgreens made the move after meeting late this week with top brass at Theranos, including CEO Elizabeth Holmes. Said meeting came about after stories questioning the viability of the startup's technology. Walgreens was also unaware of the FDA's surprise inspection of Theranos facilities in August and September, according to sources.
- Previously: Theranos chief Holmes says technology sound (Oct. 21)
- Related tickers: Abbot Labs (NYSE:ABT), Quest Diagnostics (NYSE:DGX), Lab Corp. (NYSE:LH), Roche Holding (OTCQX:RHHBY)
Thu, Oct. 22, 4:30 PM
- Patient dosing is underway in a Phase 3 clinical trial, called SURPASS, evaluating Chimerix's (NASDAQ:CMRX) lead product candidate brincidofovir in kidney transplant recipients who are seropositive for cytomegalovirus (CMV). The primary endpoint of the 520-subject non-inferiority study is the incidence of CMV disease compared to valganciclovir [Roche's (OTCQX:RHHBY) Valcyte] over 100 days. According to clinicaltrials.gov, the estimated study completion date is February 2017.
- The company is also conducting a Phase 3 study for the prevention of clinically significant CMV infection in patients undergoing hematopoietic cell transplant (HCT). Enrollment was completed in June. Top-line data from this trial, called SUPPRESS, are expected in early 2016.
- Brincidofovir is a broad spectrum antiviral under development for the prevention and treatment of clinically significant infections caused by DNA viruses. It is an oral nucleotide that has shown antiviral activity in vitro against all five families of DNA viruses that affect humans including CMV, adenovirus, BK virus and herpes simplex viruses.
Thu, Oct. 22, 8:20 AM
- Roche (OTCQX:RHHBY) discloses that its breast cancer med, Kadcyla (ado-trastuzumab emtansine) failed to achieve its primary efficacy endpoint in a clinical trail, GATSBY, assessing it for the treatment of HER2-positive advanced gastric cancer. The company intends to present the data at a future medical conference.
- The company is developing Kadcyla with Immunogen (NASDAQ:IMGN), who entered into a royalty purchase agreement with TPG Special Situations Partners to monetize its Kadcyla-related royalties earlier this year.
- Previously: ImmunoGen raises $194M via royalty transaction (March 30)
Wed, Oct. 21, 12:44 PM
- During a technology conference in California hosted by the Wall Street Journal, Theranos CEO Elizabeth Holmes defended her company and its technology against critics who claim things are not what they seem at the high-flying early-stage firm.
- She said the company has moved away from one of its devices only briefly as it proceeds to getting FDA clearance for all of its tests. She also cites her personal involvement in enacting a law in Arizona that allows patients to get blood tests without a doctor's order, saying, "I personally in Arizona worked very hard to change the law. I can't do that without knowing that the tests that are offered are of the highest quality."
- Related tickers: (ABT +1.2%)(OTCQX:RHHBY -1%)(LH -1.2%)(DGX -0.7%)
- Previously: Upstart Theranos has arrived, the ax grinding has begun (Oct. 16)
- Previously: FDA clears upstart Theranos' test system (July 2)
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world?s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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