Takeda reports Q3 FY2016 results and improves year-end outlook

On February 1, 2017 Takeda reported Q3 FY2016 results (Press release, Takeda, FEB 1, 2017, View Source [SID1234517617]).

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Strong Q3 year-to-date (YTD) results propelled by Growth Drivers

Underlying Revenue grew +7.4%, with Takeda’s Growth Drivers (GI, Oncology, CNS and Emerging Markets) delivering growth of +15.5%, and Underlying Revenue growth across all regions (U.S. +14.4%, Japan +5.0%, Europe & Canada +4.6%, Emerging Markets +4.9%).
Reported revenue declined -5.6%, due to unfavorable currencies (-8.4pp) and the impact of divestitures (-4.5pp).
Underlying Core Earnings grew +23.5%, with the Core Earnings margin increasing by 2.1pp. Despite unfavorable currencies and the negative impact of divestitures, reported operating profit was up +29.8%, benefiting from strong underlying growth and a one-time gain on the Teva JV transaction that was booked in Q1 FY2016.
Underlying Core EPS was up +31.7%, reflecting strong Core Earnings growth and a lower tax rate due to timing. Reported EPS was 212 yen, an increase of +46.3% from 145 yen in the prior year.
Adjusted Operating Free Cash Flow was up +9.3% to 120.0 billion yen.

Takeda’s Growth Drivers delivered +15.5% Underlying Revenue growth

GI underlying revenue +37.9%, driven by ENTYVIO and TAKECAB.
Oncology underlying revenue +6.3%, supported by uptake of NINLARO and ADCETRIS.
CNS underlying revenue +28.3%, underpinned by strong performance of TRINTELLIX.
Emerging Markets underlying revenue +4.9%, with robust growth in the key markets of Brazil (+9.5%), China (+8.0%) and Russia (+7.3%).

Christophe Weber, President and Chief Executive Officer of Takeda, commented:
"Our impressive year-to-date performance is evidence of how our strategic transformation is driving profitable growth. We are pleased to report that Takeda’s Growth Drivers (GI, Oncology, CNS and Emerging Markets) have maintained their strong momentum, driven in particular by the continued success of ENTYVIO and NINLARO. This gives us the confidence to improve the full-year outlook for FY2016.
Furthermore, we continue to make strong progress against our strategic transformation. In December, we announced our plan to sell Takeda’s shareholding in Wako Pure Chemical, and in January, we announced our plan to acquire ARIAD Pharmaceuticals. This deal will significantly enhance our global oncology portfolio and create value for our shareholders."

Reported Results for Q3 FY2016 YTD (April - December)
(billion yen) FY2015
Q3 YTD FY2016
Q3 YTD Growth
Reported Underlying2
Revenue 1,393.3 1,315.8 -5.6% +7.4%
Core Earnings1 267.9 228.3 -14.8% +23.5%
Operating Profit 167.5 217.4 +29.8% N/A
Net Profit3 113.6 165.7 +45.8% N/A
EPS 145 yen 212 yen +46.3% N/A
Core EPS 240 yen 229 yen -4.4% +31.7%
1 Core Earnings is calculated by taking reported Gross Profit and deducting SG&A expenses and R&D expenses. In addition, certain other items that are non-core in nature and significant in value may also be adjusted.
2 Underlying growth compares two periods of financial results on a common basis, showing the ongoing performance of the business excluding the impact of foreign exchange and divestitures from both periods.
3 Attributable to the owners of the company.

FY2016 Management Guidance: Takeda increases management guidance for Underlying Core Earnings to "High-teen growth" and Underlying Core EPS to "Mid-teen growth"


Previous Guidance
(Oct 28, 2016) Revised Guidance
(Feb 1, 2017)
Underlying Revenue

Mid-single digit growth(%) Mid-single digit growth(%)
Underlying Core Earnings

Mid- to high-teen growth(%) High-teen growth(%)
Underlying Core EPS

Low- to mid-teen growth(%) Mid-teen growth(%)
Annual Dividend per Share 180 yen 180 yen

FY2016 Reported Forecast: increased Core Earnings of 16-17 billion yen will offset accelerated 1 and potential impacts of the ARIAD acquisition2

(billion yen) Previous Forecast
(Oct 28, 2016) Revised Forecast
(Feb 1, 2017)
Revenue 1,670.0 1,700.0
R&D Expenses -310.0 -315.0
Operating Profit 135.0 135.0
Net Profit3 91.0 93.0
EPS 116 yen 119 yen
Exchange Rate (annual average) 1 US$=104 yen
1 euro=117 yen 1 US$=109 yen
1 euro=120 yen
1 The revised forecast includes costs related to the R&D transformation program of 47 billion yen in FY2016 (previous forecast was 40 billion yen). Total estimated costs for the program are unchanged at 75 billion yen (28 billion yen expected in FY2017).
2 Potential impacts to operating profit of approximately minus 9-10 billion yen are expected in FY2016 related to the acquisition of ARIAD Pharmaceuticals, Inc.
3 Attributable to the owners of the company

For more details on Takeda’s Q3 FY2016 YTD results and other financial information please visit View Source

Roche reports good results in 2016

On February 1, 2017 Roche reported good results for 2016 (Press release, Hoffmann-La Roche, FEB 1, 2017, View Source [SID1234517616]).

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Roche reports good results in 2016

Group sales increase 4%1 at constant exchange rates, 5% in Swiss francs

Pharmaceuticals Division sales up 3%, mainly driven by cancer medicines Perjeta and Herceptin as well as
Actemra/RoActemra

Diagnostics Division sales grow 7%, driven primarily by immunodiagnostic solutions

Successful launches of four new medicines; five US FDA breakthrough therapy designations granted

Emicizumab prophylaxis shows positive results in people with haemophilia A in pivotal trial

Successful launch of new immunochemistry instrument cobas e 801

Core earnings per share up 5% at constant exchange rates, 8% in Swiss francs

Board proposes dividend increase to CHF 8.20

Outlook for 2017: sales expected to grow low- to mid-single digit, at constant exchange rates. Core earnings per share targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.


Key figures 2016
CHF millions % change
2016 2015 CER1 CHF
Group sales 50,576 48,145 +4 +5
Pharmaceuticals Division 39,103 37,331 +3 +5
Diagnostics Division 11,473 10,814 +7 +6
Core operating profit 18,420 17,542 +4 +5
Core EPS – diluted (CHF) 14.53 13.49 +5 +8
IFRS net income 9,733 9,056 +7 +7

Commenting on the Group’s results, Roche CEO Severin Schwan said: «I am pleased that we have again reached all our financial targets while our product portfolio has made significant progress. We brought four new medicines to market in less than a year, including our first cancer immunotherapy Tecentriq. In Diagnostics, we launched an immunodiagnostic instrument, the cobas e 801, which represents a major step forward in realising the connected laboratory. We again look forward to a number of important clinical read-outs and regulatory milestones for Roche medicines this year, reflecting our broad and innovative product pipeline.»

Group results
Good performance in both divisions
Group sales rose 4% to CHF 50.6 billion. Despite high investments in the launch of new products and product development, core EPS grew faster than sales (+5%). Core EPS growth reflects the good underlying business performance and an impact from changes to the Group’s Swiss pension plans. IFRS net income was up 7% at constant exchange rates and in Swiss francs.

Sales in the Pharmaceuticals Division rose 3% to CHF 39.1 billion, driven by growth of Perjeta, Herceptin and Actemra/RoActemra, partially offset by lower sales of Pegasys, Tarceva and Lucentis.

In the US, Pharmaceuticals sales advanced 3%, led by the respiratory medicines Xolair and Esbriet. The recently launched medicines Tecentriq and Alecensa contributed to the growth as well. Sales of eye drug Lucentis and cancer medicines Avastin and Tarceva declined due to growing use of other therapeutic options. In Europe, sales growth of 4% was driven by Perjeta, Actemra/RoActemra and MabThera/Rituxan. In Japan, sales grew 1% despite the biennial price cuts and a special price reduction rule for best-selling medicines. Tamiflu, Alecensa and Actemra/RoActemra were key sales contributors. In the International region, sales gained 4%, driven by the Asia-Pacific and Latin America subregions.

Diagnostics divisional sales increased 7% to CHF 11.5 billion – above market growth. Centralised and Point of Care Solutions2 was the main contributor, led by its immunodiagnostics business.

In the EMEA3 (+2%) and North America (+3%) regions, the division’s largest markets, the sales increases were led by Centralised and Point of Care Solutions. Sales growth in North America was partially offset by a decline in Diabetes Care business, which faced continued pricing pressure. The sales increase in Asia-Pacific (+16%) was mainly driven by China. In Latin America, sales advanced 18%. Sales growth in Japan (+2%) was also led by the Centralised and Point of Care Solutions business.

High number of launches in Pharmaceuticals
Roche recently launched four new medicines: Cotellic (advanced melanoma), Alecensa (lung cancer), Venclexta (chronic lymphocytic leukemia; jointly commercialised with AbbVie) and Tecentriq (bladder and lung cancer). In addition, five FDA breakthrough therapy designations were granted for Roche medicines in 2016. A major highlight was the US launch of Roche’s cancer immunotherapy medicine Tecentriq in May. It is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years. Furthermore, in October the FDA cleared Tecentriq for use in previously treated metastatic non-small cell lung cancer (NSCLC). The pivotal Oak trial showed that people with this form of lung cancer who received Tecentriq live significantly longer, regardless of their PD-L1 status, compared with those receiving chemotherapy. Additional data presented at the ECTRIMS4 congress in September showed that Roche’s ocrelizumab increased disease control in both relapsing and primary progressive multiple sclerosis (RMS and PPMS). Roche is seeking regulatory approval for this medicine in RMS and PPMS in the US and the EU. The US FDA’s action date for a decision is March 28, 2017.

Roche also presented other important clinical results in 2016. A pivotal study in a group of people with haemophilia A (Haven 1) showed that prophylaxis with emicizumab led to a significant reduction in the number of bleeds over time. A phase III study by Chugai (J-Alex) found that first-line treatment with Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib, the current standard of care, in people with ALK-positive NSCLC.

While Gazyva/Gazyvaro showed positive results in a major clinical trial (Gallium) in follicular lymphoma, a separate trial (Goya) of the medicine in diffuse large B-cell lymphoma, did not reach its primary study goal. Also in 2016, Roche presented data from the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels. Initially combined with a steroid regimen, Actemra/RoActemra more effectively sustained remission compared to a steroid-only regimen in people with newly diagnosed and relapsing GCA.

Further broadening the Diagnostics portfolio
During 2016, Roche added nine key instruments and tests to its comprehensive portfolio, further improving decision-making in healthcare, and supporting laboratories’ efforts to increase efficiency. Among the new instruments are the cobas e 801 immunoassay module, the CoaguChek INRange system to monitor vitamin K antagonist therapy, and the Accu-Chek Guide, a next-generation blood glucose monitoring system.

The US-FDA approved two accompanying diagnostics: the Ventana PD-L1 (SP142) test is a complementary diagnostic which determines PD-L1 status of patients with bladder and lung cancer. The cobas EGFR Mutation test v2 is a companion diagnostic for lung cancer medicine Tarceva. The FDA also granted premarket clearance and a CLIA5 waiver for the cobas Liat Influenza A/B & RSV test. This is the first point-of-care test that extends molecular testing on the Liat system beyond influenza A/B and Streptococcus A to include respiratory syncytial virus (RSV). The FDA also approved Roche tests for the detection of Zika virus.

Outlook for 2017
In 2017, Roche expects sales to grow low- to mid-single digit, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to further increase its dividend in Swiss francs.

Bristol-Myers Squibb Announces European Patent Office Decision on Sprycel

On February 1, 2017 Bristol-Myers Squibb Company (NYSE: BMY) reported that the European Patent Office (EPO) upheld a decision with regard to European Patent No. 1169038 (the ‘038 patent), the Composition of Matter patent covering dasatinib, the active ingredient in Sprycel (Press release, Bristol-Myers Squibb, FEB 1, 2017, View Source [SID1234517615]). The EPO upheld a decision that found the patent to be invalid.

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This decision does not impact our patents outside of the EU or other Sprycel-related patents.

BMS has a long-standing heritage in oncology. Sprycel will continue to be a significant asset in our broad oncology portfolio and an important treatment option for patients living with chronic myeloid leukemia (CML).

U.S. FDA-APPROVED INDICATIONS FOR SPRYCEL (dasatinib)

SPRYCEL (dasatinib) is indicated for the treatment of adults with:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
IMPORTANT SAFETY INFORMATION

Myelosuppression:

Treatment with SPRYCEL is associated with severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients with advanced phase CML or Ph+ ALL than in patients with chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities.

In patients with chronic phase CML, perform complete blood counts (CBCs) every 2 weeks for 12 weeks, then every 3 months thereafter, or as clinically indicated
In patients with advanced phase CML or Ph+ ALL, perform CBCs weekly for the first 2 months and then monthly thereafter, or as clinically indicated
Myelosuppression is generally reversible and usually managed by withholding SPRYCEL temporarily and/or dose reduction
In clinical studies, myelosuppression may have also been managed by discontinuation of study therapy
Hematopoietic growth factor has been used in patients with resistant myelosuppression
Bleeding-Related Events:

SPRYCEL caused thrombocytopenia in human subjects. In addition, dasatinib caused platelet dysfunction in vitro. In all CML or Ph+ ALL clinical studies, ≥grade 3 central nervous system (CNS) hemorrhages, including fatalities, occurred in <1% of patients receiving SPRYCEL. Grade 3 or greater gastrointestinal hemorrhage, including fatalities, occurred in 4% of patients and generally required treatment interruptions and transfusions. Other cases of ≥grade 3 hemorrhage occurred in 2% of patients.

Most bleeding events in clinical studies were associated with severe thrombocytopenia
Concomitant medications that inhibit platelet function or anticoagulants may increase the risk of hemorrhage
Fluid Retention:

SPRYCEL may cause fluid retention. After 5 years of follow-up in the randomized newly diagnosed chronic phase CML study (n=258), grade 3/4 fluid retention was reported in 5% of patients, including 3% of patients with grade 3/4 pleural effusion. In patients with newly diagnosed or imatinib resistant or intolerant chronic phase CML, grade 3/4 fluid retention occurred in 6% of patients treated with SPRYCEL at the recommended dose (n=548). In patients with advanced phase CML or Ph+ ALL treated with SPRYCEL at the recommended dose (n=304), grade 3/4 fluid retention was reported in 8% of patients, including grade 3/4 pleural effusion reported in 7% of patients.

Patients who develop symptoms of pleural effusion or other fluid retention, such as new or worsened dyspnea on exertion or at rest, pleuritic chest pain, or dry cough should be evaluated promptly with a chest x-ray or additional diagnostic imaging as appropriate
Fluid retention events were typically managed by supportive care measures that may include diuretics or short courses of steroids
Severe pleural effusion may require thoracentesis and oxygen therapy
Consider dose reduction or treatment interruption
Cardiovascular Events:

After 5 years of follow-up in the randomized newly diagnosed chronic phase CML trial (n=258), the following cardiac adverse events occurred:

Cardiac ischemic events (3.9% dasatinib vs 1.6% imatinib), cardiac related fluid retention (8.5% dasatinib vs 3.9% imatinib), and conduction system abnormalities, most commonly arrhythmia and palpitations (7.0% dasatinib vs 5.0% imatinib). Two cases (0.8%) of peripheral arterial occlusive disease occurred with imatinib and 2 (0.8%) transient ischemic attacks occurred with dasatinib
Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pulmonary Arterial Hypertension (PAH):

SPRYCEL may increase the risk of developing PAH, which may occur any time after initiation, including after more than 1 year of treatment. Manifestations include dyspnea, fatigue, hypoxia, and fluid retention. PAH may be reversible on discontinuation of SPRYCEL.

Evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to initiating SPRYCEL and during treatment. If PAH is confirmed, SPRYCEL should be permanently discontinued
QT Prolongation:

In vitro data suggest that dasatinib has the potential to prolong cardiac ventricular repolarization (QT interval).

In clinical trials of patients treated with SPRYCEL at all doses (n=2440), 16 patients (<1%) had QTc prolongation reported as an adverse reaction. Twenty-two patients (1%) experienced a QTcF >500 ms
In 865 patients with leukemia treated with SPRYCEL in five Phase 2 single-arm studies, the maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7.0 to 13.4 ms
SPRYCEL may increase the risk of prolongation of QTc in patients including those with hypokalemia or hypomagnesemia, patients with congenital long QT syndrome, patients taking antiarrhythmic medicines or other medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline therapy
Correct hypokalemia or hypomagnesemia prior to and during SPRYCEL administration
Severe Dermatologic Reactions:

Cases of severe mucocutaneous dermatologic reactions, including Stevens-Johnson syndrome and erythema multiforme, have been reported in patients treated with SPRYCEL.

Discontinue permanently in patients who experience a severe mucocutaneous reaction during treatment if no other etiology can be identified
Tumor Lysis Syndrome (TLS):

TLS has been reported in patients with resistance to prior imatinib therapy, primarily in advanced phase disease.

Due to potential for TLS, maintain adequate hydration, correct uric acid levels prior to initiating therapy with SPRYCEL, and monitor electrolyte levels
Patients with advanced stage disease and/or high tumor burden may be at increased risk and should be monitored more frequently
Embryo-Fetal Toxicity:

Based on limited human data, SPRYCEL can cause fetal harm when administered to a pregnant woman. Hydrops fetalis, fetal leukopenia and fetal thrombocytopenia have been reported with maternal exposure to SPRYCEL. Transplacental transfer of dasatinib has been measured in fetal plasma and amniotic fluid at concentrations comparable to those in maternal plasma.

Advise females of reproductive potential to avoid pregnancy, which may include the use of effective contraception, during treatment with SPRYCEL and for 30 days after the final dose
Lactation:

No data are available regarding the presence of dasatinib in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, dasatinib is present in the milk of lactating rats.

Because of the potential for serious adverse reactions in nursing infants from SPRYCEL, breastfeeding is not recommended during treatment with SPRYCEL and for 2 weeks after the final dose
Drug Interactions:

SPRYCEL is a CYP3A4 substrate and a weak time-dependent inhibitor of CYP3A4.

Drugs that may increase SPRYCEL plasma concentrations are:
CYP3A4 inhibitors: Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If administration of a potent CYP3A4 inhibitor cannot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction should be considered
Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). If SPRYCEL must be administered with a strong CYP3A4 inhibitor, a dose decrease or temporary discontinuation should be considered
Grapefruit juice may also increase plasma concentrations of SPRYCEL and should be avoided
Drugs that may decrease SPRYCEL plasma concentrations are:
CYP3A4 inducers: If SPRYCEL must be administered with a CYP3A4 inducer, a dose increase in SPRYCEL should be considered
Strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital) should be avoided. Alternative agents with less enzyme induction potential should be considered. If the dose of SPRYCEL is increased, the patient should be monitored carefully for toxicity
St John’s Wort may decrease SPRYCEL plasma concentrations unpredictably and should be avoided
Antacids may decrease SPRYCEL drug levels. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of SPRYCEL
H 2 antagonists/proton pump inhibitors (eg, famotidine and omeprazole): Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump inhibitors is likely to reduce SPRYCEL exposure. Therefore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended
Drugs that may have their plasma concentration altered by SPRYCEL are:
CYP3A4 substrates (eg, simvastatin) with a narrow therapeutic index should be administered with caution in patients receiving SPRYCEL
Adverse Reactions:

The safety data reflects exposure to SPRYCEL at all doses tested in clinical studies including 324 patients with newly diagnosed chronic phase CML and 2388 patients with imatinib resistant or intolerant chronic or advanced phase CML or Ph+ ALL.

The median duration of therapy in all 2712 SPRYCEL-treated patients was 19.2 months (range 0–93.2 months). Median duration of therapy in:

1618 patients with chronic phase CML was 29 months (range 0–92.9 months)
Median duration for 324 patients in the newly diagnosed chronic phase CML trial was approximately 60 months
1094 patients with advanced phase CML or Ph+ ALL was 6.2 months (range 0–93.2 months)
In the newly diagnosed chronic phase CML trial, after a minimum of 60 months of follow-up, the cumulative discontinuation rate for 258 patients was 39%.

In the overall population of 2712 SPRYCEL-treated patients, 88% of patients experienced adverse reactions at some time and 19% experienced adverse reactions leading to treatment discontinuation.

Among the 1618 SPRYCEL-treated patients with chronic phase CML, drug-related adverse events leading to discontinuation were reported in 329 (20.3%) patients.

In the newly diagnosed chronic phase CML trial, drug was discontinued for adverse reactions in 16% of SPRYCEL-treated patients with a minimum of 60 months of follow-up
Among the 1094 SPRYCEL-treated patients with advanced phase CML or Ph+ ALL, drug-related adverse events leading to discontinuation were reported in 191 (17.5%) patients.

Patients ≥65 years are more likely to experience the commonly reported adverse reactions of fatigue, pleural effusion, diarrhea, dyspnea, cough, lower gastrointestinal hemorrhage, and appetite disturbance, and more likely to experience the less frequently reported adverse reactions of abdominal distention, dizziness, pericardial effusion, congestive heart failure, hypertension, pulmonary edema and weight decrease, and should be monitored closely.

In newly diagnosed chronic phase CML patients:
Drug-related serious adverse events (SAEs) were reported for 16.7% of SPRYCEL-treated patients. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%)
The most common adverse reactions (≥15%) included myelosuppression, fluid retention, and diarrhea
Grade 3/4 laboratory abnormalities included neutropenia (29%), thrombocytopenia (22%), anemia (13%), hypophosphatemia (7%), hypocalcemia (4%), elevated bilirubin (1%), and elevated creatinine (1%)
In patients resistant or intolerant to prior imatinib therapy:
Drug-related SAEs were reported for 26.1% of SPRYCEL-treated patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%)
The most common adverse reactions (≥15%) included myelosuppression, fluid retention events, diarrhea, headache, fatigue, dyspnea, skin rash, nausea, hemorrhage and musculoskeletal pain
Grade 3/4 hematologic laboratory abnormalities in chronic phase CML patients resistant or intolerant to prior imatinib therapy who received SPRYCEL 100 mg once daily with a minimum follow up of 60 months included neutropenia (36%), thrombocytopenia (24%), and anemia (13%). Other grade 3/4 laboratory abnormalities included: hypophosphatemia (10%), and hypokalemia (2%)
Among chronic phase CML patients with resistance or intolerance to prior imatinib therapy, cumulative grade 3/4 cytopenias were similar at 2 and 5 years including: neutropenia (36% vs 36%), thrombocytopenia (23% vs 24%), and anemia (13% vs 13%)
Grade 3/4 elevations of transaminases or bilirubin and Grade 3/4 hypocalcemia, hypokalemia, and hypophosphatemia were reported in patients with all phases of CML
Elevations in transaminases or bilirubin were usually managed with dose reduction or interruption
Patients developing Grade 3/4 hypocalcemia during the course of SPRYCEL therapy often had recovery with oral calcium supplementation

Clovis Oncology and Strata Oncology Announce Collaboration to Accelerate Enrollment in Rucaparib Prostate Cancer Development Program

On February 1, 2017 Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. reported an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment (Press release, Clovis Oncology, FEB 1, 2017, View Source [SID1234517614]).

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Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca (rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).

Strata Oncology is conducting the Strata Trial, an observational study that provides next-generation sequencing at no cost to all advanced cancer patients at its affiliated cancer centers and hospitals. Strata then refers patients with selected mutations to physicians involved in its pharmaceutical partners’ targeted clinical trials. Strata seeks to fulfill the promise of precision medicine by improving the number of patients identified with specific mutations appropriate for ongoing clinical trials.

Under the terms of the agreement, Strata will exclusively refer BRCA and ATM-mutated advanced prostate cancer patients for consideration of enrollment to Clovis’ TRITON2 and TRITON3 clinical trials of rucaparib. The Strata Trial is available at an expanding network of select cancer centers and hospitals nationwide.

"We’re delighted to work with Clovis Oncology in advancing development of their highly promising drug rucaparib for prostate cancer patients," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "We are confident that we will identify a number of mutant BRCA and ATM prostate cancer patients through the Strata Trial, and accelerate enrollment in the TRITON2 and TRITON3 clinical trials."

"Following rucaparib’s initial U.S. approval in ovarian cancer, we are committed to rapidly enrolling additional trials and expanding rucaparib development into broader indications, including prostate," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Through our work with Strata, we seek to address the significant challenge of identifying and enrolling the right patients – in this case, patients with advanced prostate cancer who possess mutations of BRCA and/or ATM – in support of advancing our precision medicine clinical trials and potentially providing rucaparib to a broader population of patients who may benefit."