Mon, Oct. 19, 9:32 AM
- Seattle Genetics (NASDAQ:SGEN) initiates a 110-subject, randomized, open-label, multi-center Phase 2 clinical trial assessing ADCETRIS (brentuximab vedotin), in combination with Roche's (OTCQX:RHHBY) Rituxan (rituximab) and bendamustine, in relapsed/refractory patients with CD30-expressing diffuse large B-cell lymphoma (DLBCL). Participants will receive Rituxan and bendamustine, agents commonly used to treat DLBCL, with or without ADCETRIS every three weeks for six cycles. The primary endpoint is the comparison of objective response rates between the treatment arms. Secondary endpoints include progression-free survival, complete remission rate, duration of response and overall survival. The trial is being conducted in ~50 sites across North America and Europe.
- Previously presented data from a Phase 2 study assessing ADCETRIS alone or with Rituxan every three weeks in relapsed/refractory CD30-positive non-Hodgkin lymphoma patients showed an objective response rate of 44% (19% complete remissions) in the ADCETRIS arm and an objective response rate of 46% (15% complete remissions) in the combination arm. The most common treatment-emergent adverse event at least Grade 3 was neutropenia (abnormally low neutrophil [type of white blood cell] count).
- ADCETRIS, an antibody-drug conjugate, is being evaluated in more than 30 ongoing clinical trials.
Mon, Oct. 19, 7:59 AM
- The FDA approves Roche's (OTCQX:RHHBY) cobas HBV and cobas HCV viral load tests, both of which will be performed on its automated cobas 6800 and cobas 8800 laboratory systems. The tests can be run simultaneously on the analyzers, which can generate up to 96 results in less than 3.5 hours.
- Its tests for HIV-1 viral load and cytomegalovirus (CMV) viral load are still under agency review.
Fri, Oct. 16, 2:00 PM
- Start-ups, especially biotechs, typically enjoy an "image honeymoon" period with stakeholders, constituency groups and the press as they try to pull themselves up from a "little company that could" to establishing themselves as sustainable enterprises and legitimate players in their respective markets. Anyone remotely familiar to the biotech arena knows how extraordinarily difficult it is to pull this off so it is rare to see anything but encouraging references to the upstarts as they pursue their visions of successful disruptions and the monetary rewards that follow. Once the company gets momentum and grows in size and valuation, the situation evolves as insiders position themselves for the big payday and competitors wake up to the potential threat. Those who feel threatened or disadvantaged typically use the press to drum up negative news either as "payback" for being excluded from the money train or to dim the aura of the upstart's halo.
- Palo Alto, CA-base Theranos is a case in point. The medical diagnostics firm, started by a teen-aged Stanford University drop-out in 2003, now sports a $9B market cap based on the disruptive potential of its automated microfluidics-based system to the $50B global diagnostics industry. Founder Elizabeth Holmes is a billionaire at age 31. The enormous amount of money at stake inevitably leads to "haves" and "have-nots."
- An article published in the Wall Street Journal yesterday is a superb example of this dynamic. The reporter based his article on information provided by four former (disgruntled) employees who allege that Theranos' dream is quite a distance from reality, saying, among other things, that most of the tests currently being offered are performed by traditional instruments rather than its proprietary Edison system. Other missteps cited in the article, such as providing an incorrect result, occur every day in the diagnostics industry. The selective use of individual examples paints a very biased view of reality. Some of the information may be true, but it is impossible to determine fact from fiction. No one said being a billionaire was easy.
- Previously: FDA clears upstart Theranos' test system (July 2)
- Previously: Upstart Theranos receives CLIA waiver for test system clearing the way for rapid diagnostics in Wellness Center setting (July 16)
- Related tickers: (LH +0.7%)(DGX +1.5%)(ABT -0.4%)(OTCQX:RHHBY +1.6%)
Thu, Oct. 15, 11:42 AM
- Cerulean Pharma (CERU +2.9%) completes enrollment of 110 subjects in a randomized Phase 2 clinical trial evaluating lead product candidate CRLX101, in combination with Roche's (OTCQX:RHHBY +1%) Avastin (bevacizumab), in third- and fourth-line relapsed renal cell carcinoma (RCC). The primary endpoint is progression-free survival per RECIST 1.1 criteria. Top-line data are expected in H1 2016.
- CRLX101 is a nanoparticle-drug conjugate which is designed to concentrate in tumors and slowly release the cytotoxin camptothecin.
Mon, Oct. 12, 10:44 AM
- Thinly traded nano cap Celsion (CLSN +9.2%) moves up on a healthy 10x surge in volume in response to its announcement of positive preclinical results for its GEN-1 IL-12 immunotherapy. Specifically, the combination of GEN-1 IL-12 with Roche's (OTCQX:RHHBY +0.7%) Avastin (bevacizumab) and J&J's (JNJ +0.9%) Doxil (doxorubicin HCl liposome injection) showed a greater than 98% reduction in tumor burden compared to the combination of Avastin and Doxil alone in an ovarian cancer cell line called SKOV3 implanted into immunocompromised mice.
- GEN-1 is an immunotherapy consisting of an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system. It is administered via an intraperitoneal (body cavity) injection.
- The company is currently enrolling patients in a Phase 1b trial called OVATION. A Phase 1/2 combination study should commence in mid-2016.
Mon, Oct. 12, 7:17 AM
- The Netherlands' National Institute for Public Health and the Environment (RIVM) awards a five-year contract to Roche (OTCQX:RHHBY) to implement its cobas HPV test as the first-line primary screening test in its national cervical cancer screening program, expected to start in H2 2016. It will be the first country in the world with an organized cervical screening program to fully transition from the Pap test to primary HPV screening with the aim of improving the detection rate of pre-cancerous disease.
- The cobas HPV test is the only FDA-cleared HPV assay that identifies HPV 16 and 18, the highest risk types, in addition to the other 12 HPV types. All are identified simultaneously as a pooled result from one cervical swab sample. The test will be performed on the automated cobas 4800 System.
- The Dutch program includes a longer time interval between routine screening visits as well as an option for women to self-collect their cervical samples.
- Financial terms are not disclosed.
Fri, Oct. 9, 7:46 AM
- Roche (OTCQX:RHHBY) acquires Berkeley, CA-based privately held Adheron Therapeutics. Under the terms of the deal, Adheron shareholders will receive $105M upfront plus potential milestones of up to $475M.
- Adheron has developed a technology that disrupts immune cell adhesion through a cell surface protein called Cadherin-11, which has the potential for treatments for a range of inflammatory and autoimmune diseases. Its lead product candidate is SDP051, a humanized monoclonal antibody targeting Cadherin-11 that just completed Phase 1 development.
- Cadherin-11, a protein that acts as an "adhesive" between cells, is a key mediator of joint destruction in rheumatoid arthritis and plays a key role in fibrotic pathology.
Tue, Oct. 6, 9:01 AM
- Final results from Roche's (OTCQX:RHHBY) Phase 3 coBRIM clinical trial showed a significant improvement in overall survival (OS) in treatment-naive BRAF V600 mutation-positive advanced melanoma patients treated with the combination of Cotellic (cobimetinib) and Zelboraf (vemurafenib) compared to Zelboraf alone. The specific data will be presented at an upcoming medical conference.
- Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Cotellic + Zelboraf for the treatment of advanced melanoma. A final decision by the European Commission is expected by the end of the year. The FDA's action date for the combo is November 11.
Mon, Oct. 5, 8:55 AM
- Roche (OTCQX:RHHBY) launches its new CE-Mark'd high throughput analyzer for HbA1c testing for diabetics, the cobas c 513, which replaces its existing analyzer, the COBAS INTEGRA 800 CTS. The c 513 can process up to 400 patient results per hour, twice the throughput of INTEGRA.
- The c 513 also features direct results reporting and higher on-board test capacity (the lab can load more tests at a time).
Wed, Sep. 30, 10:02 AM
- Cerulean Pharma (CERU +4%) announces that its lead product candidate, CRLX101, achieved its pre-defined gating criteria for advancement into the second stage of an open-label Phase 2 clinical trial in patients with recurrent cisplatin-resistant ovarian, tubal and peritoneal cancer. In the study's first stage, 8 of 15 (53%) of patients treated with CRLX101, in combination with Roche's (OTCQX:RHHBY +1.3%) Avastin (bevacizumab), achieved at least six months of progression-free survival (PFS). This compared favorably to the historical expectation of ~20%.
- CRLX101 is a nanoparticle-drug conjugate (NDC) that delivers its anti-cancer payload, camptothecin, inside tumor cells. It inhibits topoisomerase 1 (topo 1), an enzyme involved in cellular replication and hypoxia-inducible factor-1, which is a master regulator of cancer cell survival mechanisms.
- The FDA has designated CRLX101 an Orphan Drug for the treatment of ovarian cancer and for Fast Track review, in combination with Avastin, for the treatment of metastatic renal cell carcinoma.
Mon, Sep. 28, 7:44 AM
- A Phase 3 clinical trial, called ORATORIO, evaluating Roche's (OTCQX:RHHBY) investigational ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint of demonstrating reduced progression of clinical disability compared to placebo. The endpoint was defined as an increase in Expanded Disability Status Score (EDSS) that was sustained for at least 12 weeks. The incidence of serious adverse events was similar to placebo, most were infusion-related reactions. The results will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain on October 10 (Abstract #228).
- Head of Global Product Development Sandra Horning, M.D., says, "People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease and there are no approved treatments for this debilitating condition. Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in [PPMS]."
- Roche intends to pursue marketing authorization for ocrelizumab in both relapsing MS and PPMS. Late-stage study data will be submitted to the FDA in early 2016. About 10% of MS patients have PPMS.
Sun, Sep. 27, 7:00 PM
- Two Phase 2 clinical trials assessing Roche's (OTCQX:RHHBY) atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) met their primary endpoints.
- The first, POPLAR, showed that patients with recurrent NSCLC whose tumors expressed medium/high levels of PD-L1 who received atezolizumab experienced a statistically significant survival benefit compared to chemotherapy (p=0.014). Median survival had not yet been reached.
- The second, single-arm BIRCH, showed a 27% objective response rate in patients treated with atezolizumab whose cancer had progressed on prior therapies and also expressed the highest level of PD-L1.
- The data were presented at the European Cancer Congress in Vienna, Austria.
- In February 2015, the FDA designated atezolizumab a Breakthrough Therapy for the treatment of PD-L1-positive NSCLC patients whose disease worsened during or after standard treatments. The company has seven ongoing Phase 3 studies of the PD-L1 antagonist, alone or in combination with other medicines, for the treatment of various types of lung cancer.
Sun, Sep. 27, 6:29 PM
- Results from a 311-subject Phase 2 clinical trial, IMvigor 210, showed that 27% of patients with locally advanced or metastatic urothelial carcinoma (mUC) treated with Roche's (OTCQX:RHHBY) atezolizumab (formerly MPDL3280A) experienced tumor shrinkage (overall response rate or ORR). The patients in the test group had mUC with medium/high levels of PD-L1 expression and worsened after initial treatment. 92% of the responders continued to respond at data cutoff. Median duration of response was not yet reached. Median progression-free survival was 2.1 months.
- The number of adverse events was low, led by fatigue (2%) followed by decreased appetite, fever, pain, shortness of breath, anemia, liver enzyme (ALT) elevation, lung wall inflammation, hypertension and hypotension (all 1%). The results were presented at the European Cancer Congress in Vienna, Austria.
- The company intends to submit the data to global heath authorities to support approval of atezolizumab for the treatment of metastatic PD-L1-positive bladder cancer. It has Breakthrough Therapy status in the U.S. for the indication.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. It is also under development for lung cancer, soft tissue sarcoma, breast cancer and colorectal cancer.
- Previously: Mid-stage study shows Roche's atezolizumab shrinks tumors in patients with bladder cancer (July 13)
Fri, Sep. 25, 9:13 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Roche's (OTCQX:RHHBY) Cotellic (cobimetinib), in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. About half of melanoma cases are BRAF-positive.
- CHMP's positive opinion was based on results from a Phase 3 study, coBRIM, which showed a 71% increase (12.3 months vs. 7.2 months) in median progression-free survival in patients receiving the combo compared to Zelboraf alone.
- A final decision by the European Commission usually takes ~60 days.
- Cotellic was recently cleared in Switzerland for use with Zelboraf in advanced melanoma. A decision by the FDA on the combination is expected later this year.
Wed, Sep. 23, 9:32 AM
- A Phase 3 clinical trial comparing Amgen's (NASDAQ:AMGN) biosimilar candidate ABP 215 to Roche's (OTCQX:RHHBY) Avastin (bevacizumab) successfully achieved its primary endpoint of demonstrating clinical equivalence to Avastin in lung cancer patients.
- The 642-subject, randomized, double-blind, active-controlled study assessed the objective response rates of ABP 215 and bevacizumab in patients with advanced non-squamous non-small cell lung cancer receiving first-line chemotherapy with carboplatin and paclitaxel. The duration of treatment included a screening period of up to four weeks followed by up to six treatment cycles (IV infusion of 15 mg/kg every three weeks) and an end-of-treatment visit 21 days after the last dose of either ABP 215 or bevacizumab.
- ABP 215 is one of four oncology biosimilars being developed under a collaboration with Allergan (NYSE:AGN). Amgen has a total of nine biosimilars in development.
Wed, Sep. 23, 7:27 AM
- An open-label 551-subject Phase 3b/4 clinical trial, called STRIIVING, assessing the safely, efficacy and tolerability of switching from an antiretroviral therapy (ART) to ViiV Healthcare's (NYSE:PFE) (NYSE:GSK) once-daily fixed dose Triumeq (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1 infection showed that viral suppression was non-inferior (no worse than) in patients who switched to Triumeq.
- The study recruited HIV-1-positive patients from a broad range of protease inhibitor (n=234), integrase strand transfer inhibitor (n=146) and non-nuclease reverse transcriptase inhibitor (n=171)-based regimens who had similar clinical profiles. The treatment satisfaction score improved significantly for those patients who switched to Triumeq (p<0.001) although there was an increase in adverse events (AEs) (4% versus 0%). The most common AEs were nausea (10%), diarrhea (7%), fatigue (7%), upper respiratory infection (7%), cough (5%) and headache (5%).
- ViiV Healthcare Chief Scientific and Medical Officer John Pottage, M.D., says, "For clinicians, choosing among antiretroviral therapies now involves balancing efficacy with factors such as tolerability, dosing, ability to use with other medications and resistance profile. These data support the use of once-daily abacavir/dolutegravir/lamivudine as a treatment option in the switch setting for appropriate patients."
- Related tickers: (NASDAQ:GILD) (NYSE:JNJ) (NYSE:MRK) (NYSE:ABBV) (NYSE:BMY) (OTCQX:RHHBY)
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
Other News & PR