Today, 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.
Yesterday, 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)
Mon, Sep. 21, 11:54 AM
- New clinical data show that Trovagene's (TROV -4%) urine-based HPV HR Test is ~90% sensitive in detecting high-risk HPV from precancerous lesions compared to tests performed with Roche's (OTCQX:RHHBY +0.3%) cobas analyzer on cervical samples. The data were presented at the 30th International Human Papillomavirus Conference in Lisbon, Portugal.
- The results are similar to the Predictors 4 data released in April which showed its urine-based assay 91.4% sensitive for CIN Grade 3+ and 89.0% sensitive for CIN Grade 2+.
- Results from a screening study of the general population are expected in H1 2016.
- The value proposition of urine-based HPV testing more convenient, less invasive and easier to perform versus testing on cervical swabs, with acceptable sensitivity.
Fri, Sep. 18, 8:43 AM
- Thinly traded micro cap Tracon Pharmaceuticals (NASDAQ:TCON) is up 70% premarket on average volume in response to its announcement that a patient with an aggressive form of uterine cancer is experiencing an ongoing complete response after being treated with the company's investigational TRC105 in combination with Roche's (OTCQX:RHHBY) Avastin (bevacizumab). The results were presented at the 18th World Congress on Gestational Trophoblastic Diseases in Bali, Indonesia.
- The single patient was suffering from persistent and unresectable metastatic choriocarcinoma which is an aggressive form of gestational trophoblastic neoplasia (GTN), a rare form of uterine cancer. Under a compassionate use protocol, she was dosed with TRC105 10 mg/kg weekly, in combination with Avastin 10 mg/kg every other week. After 28 weeks of treatment (seven cycles), her beta human chorionic gonadotropin (bHCG), a reliable biomarker in choriocarcinoma, decreased from more than 3,000 IU/L to less than 1 IU/L from cycles four through seven, indicating a complete response.
- Choriocarcinoma is the second tumor type known to express high levels of a protein called endoglin, which plays a key role in angiogenesis (development of new blood vessels that "feed a tumor"). The other, angiosarcoma, also responds well to treatment with TRC105 and a VEGF inhibitor like Avastin.
- TRC105 is a novel antibody to endoglin.
- The company plans to initiate a Phase 2 study in GTN in Q4 and apply to the FDA for Orphan Drug status in GTN and soft tissue sarcoma by the end of the year.
Tue, Sep. 15, 11:35 AM
- The FDA approves privately-held Octapharma's NUWIQ, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with hemophilia A. The approval includes on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
- NUWIQ is the first B-domain-deleted recombinant Factor VIII derived from a human cell line, not chemically modified or fused with another protein, for the treatment of hemophilia A, which affects ~16K Americans.
- NUWIQ was cleared in Europe in August 2014.
- Related tickers: (BAX +0.3%)(BXLT -0.5%)(OTCQX:RHHBY +0.6%)(SGMO +2.4%) (OTCPK:CHGCY) (OPK +2.3%)(ALNY)(BIIB +0.5%)(OTCPK:BAYRY +0.4%)
Wed, Sep. 9, 8:37 AM
- The FDA accepts Roche's (OTCQX:RHHBY) New Drug Application (NDA) seeking clearance for Breakthrough Therapy-tagged alectinib for the treatment of patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Pfizer's Xalkori) under Priority Review, which shortens the review clock to six months from the usual ten. The PDUFA date is March 4, 2016.
- Roche licensed alectinib from Chugai Pharmaceutical in 2012. ALK-positive lung cancer, almost always with adenocarcinoma, typically occurs in younger people with a history of light or no smoking.
Fri, Sep. 4, 7:18 AM
- The FDA designates Roche's (OTCQX:RHHBY) investigational factor VIIIa-mimetic bispecific antibody, ACE910, a Breakthrough Therapy for the treatment of hemophilia A, a rare inherited blood disorder caused by a deficiency in an essential clotting protein called factor VIII. People with severe hemophilia A are susceptible to uncontrolled or difficult-to-control bleeding, including internally and frequently in the joints, which can eventually lead to the need for joint replacements.
- ACE910 is a humanized bispecific monoclonal antibody designed to simultaneously bind to factors IXa and X, thereby mimicking the cofactor function of factor VIII. It promotes blood coagulation in patients with hemophilia A regardless of whether they have developed inhibitors to factor VIII.
- Roche has development and commercial rights to ACE910 worldwide with the exception of Japan, Taiwan and Korea via an agreement with Chugai Pharmaceutical (OTCPK:CHGCY). A Phase 3 study in patients with inhibitors will commence by the end of the year followed by a Phase 3 trial in patients without inhibitors in 2016. A pediatric study will commence in 2016 as well.
- Breakthrough Therapy provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA.
Mon, Aug. 24, 1:33 PM
- Roche (OTCQX:RHHBY) has struck a deal with U.K. molecular diagnostics firm Lumora to buy "products associated with [Lumora's] unique, patent-protected Heat Elution technology for nucleic acid purification of multiple sample types including challenging formalin-fixed paraffin-embedded (FFPE) tumor samples." Terms are undisclosed.
- Roche: "Today, nucleic acid purification technology from specimens including formalin-fixed tissues can be cumbersome and inefficient. Lumora's highly differentiated proprietary methodology will enable simple and automated nucleic acid isolation in minutes instead of hours. In addition, the technology is environmentally friendly and can be applied to process a wide variety of sample types including whole blood, fecal matter, sputum, FFPE tissue and buccal swabs."
- The drug giant adds it plans to explore integrating Lumora's technology into its sequencing workflow solution.
Thu, Aug. 20, 7:10 AM
- The European Commission approves Novartis' (NYSE:NVS) Odomzo (sonidegib) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
- BCC, accounting for more than 80% of non-melanoma skin cancers, consists of abnormal, uncontrolled lesions that arise from the basal cells of the skin. Advanced BCC accounts for as many as 10% of all BCC cases.
- Odomzo is a once-daily pill that inhibits the molecular pathway called Hedgehog. It will compete with Roche's (OTCQX:RHHBY) Erivedge (vismodigib), an antagonist of part of the hedgehog signaling pathway called smoothened receptor, approved in January 2012. It will generate ~$175M in sales this year. The FDA cleared Odomzo about a month ago.
- Previously: FDA clears Novartis' Odomzo for skin cancer (July 24)
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