Top Pharma News | September – October 2017

Clovis Oncology Presents Comprehensive Dataset from Successful Phase 3 Ariel3 Maintenance Treatment Trial of Rucaparib In Advanced Ovarian Cancer at ESMO 2017

clovis-oncology

Sep. 7, 2017

Clovis Oncology has announced the first presentation of a comprehensive dataset from its Phase 3 ARIEL3 study of rucaparib at the 2017 European Society for Medical Oncology (ESMO) Congress. The ARIEL3 study successfully achieved its primary endpoint and key secondary endpoint, demonstrating improved progression-free survival (PFS) by both investigator review and blinded independent central review (BICR) in each of the three populations studied.

Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Carboplatin (pem/carbo) Demonstrated Continued Benefit in Overall Response Rates and Progression-Free Survival Compared to Pem/Carbo Alone in Patients with First-Line Nonsquamous NSCLC

merck

September 8, 2017

Merck has announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA + pem/carbo compared to pem/carbo alone (HR 0.54 [95% CI, 0.33-0.88, p=0.0067]). In addition, despite the crossover design, a trend in improvement in overall survival continues to be seen for KEYTRUDA + pem/carbo compared to pem/carbo alone (HR, 0.59 [95% CI, 0.34-1.05, p=0.03]). Findings were presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain.

AstraZeneca presented superior progression-free survival for Imfinzi in the PACIFIC trial of patients with locally-advanced unresectable lung cancer at ESMO 2017 Congress

AstraZeneca Logo

8 September 2017

AstraZeneca and MedImmune, its global biologics research and development arm, have presented the full PFS data from a planned interim analysis of the Phase III PACIFIC trial. Results show that Imfinzi (durvalumab) demonstrated a statistically-significant and clinically-meaningful improvement in PFS compared to current standard of care with active surveillance in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy (CRT).

Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer

bms-logo

September 8, 2017

Bristol-Myers Squibb Company has announced three-year overall survival (OS) data from CheckMate -017 and CheckMate -057, two pivotal Phase 3 randomized studies evaluating Opdivo versus docetaxel in patients with previously treated metastatic non-small cell lung cancer (NSCLC). In CheckMate -017, a trial in previously treated squamous NSCLC, 16% of patients treated with Opdivo were alive at three years (21/135) versus 6% of those treated with docetaxel (8/137) (HR 0.62; 95% CI: 0.48 to 0.80). In CheckMate -057, a trial in previously treated non-squamous NSCLC, 18% of patients treated with Opdivo were alive at three years (49/292) versus 9% of those treated with docetaxel (26/290) (HR 0.73; 95% CI: 0.62 to 0.88). Similar to prior reports, an OS benefit was observed across histologies, and three-year survivors included patients whose tumors expressed PD-L1 and those that did not. With three years’ minimum follow-up, no new safety signals were identified for Opdivo, and the safety profile across both trials was consistent with prior reports.

AstraZeneca’s Tagrisso shows potential as a new standard of care in 1st-line EGFR-mutated lung cancer at ESMO 2017 Congress

AstraZeneca Logo

September 8, 2017

AstraZeneca has presented the full results of the Phase III FLAURA trial, which support Tagrisso’s (osimertinib) clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). Results of the Phase III FLAURA trial were included at the Presidential Symposium I of the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, and demonstrate a superior, clinically-meaningful PFS advantage with Tagrisso compared with current SoC EGFR-TKIs (erlotinib or gefitinib).

Progression-Free Survival Data from ECHO-202 Trial of Incyte’s Epacadostat in Combination with Merck’s KEYTRUDA® (pembrolizumab) Underscore Durability of Response in Patients with Advanced Melanoma

merck

September 9, 2017

Merck and Incyte Corporation have announced updated data from the ongoing Phase 1/2 ECHO-202 trial (KEYNOTE-037) evaluating epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma. Among all patients with advanced melanoma, including treatment-naïve and treatment-experienced, data showed an overall response rate (ORR) of 56 percent (n=35/63) in patients treated with the combination of epacadostat and KEYTRUDA; median progression-free survival (PFS) was 12.4 months, with PFS rates of 65 percent at six months, 52 percent at 12 months, and 49 percent at 18 months. Results were generally consistent across dosing schedules of epacadostat combined with KEYTRUDA, including epacadostat 100 mg BID, the epacadostat dose being studied in the Phase 3 ECHO-301 trial. These results were presented at the ESMO 2017 Congress.

Lilly Builds Upon Body of Clinical Evidence for CYRAMZA® (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer

Eli Lilly Logo

September 10, 2017

At the ESMO 2017 Congress, Phase 3 RANGE data from Eli Lilly and Company were presented at the Presidential Symposium (abstract#: LBA4_PR). These are the first detailed results from the global, randomized, double-blinded, placebo-controlled RANGE study of CYRAMZA® (ramucirumab), in combination with docetaxel, in patients with advanced or metastatic urothelial carcinoma whose disease progressed on or after platinum-based chemotherapy. The data showed a statistically significant improvement in progression-free survival (PFS) in patients treated with ramucirumab plus docetaxel when compared to those who received placebo plus docetaxel, with a 46 percent prolongation in median PFS.

Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study

bms-logo

September 10, 2017

Bristol-Myers Squibb Company has announced today treatment with Opdivo (nivolumab) 3 mg/kg resulted in a significant improvement in recurrence-free survival (RFS) compared to Yervoy (ipilimumab) 10 mg/kg in patients with stage IIIb/c or stage IV melanoma following complete surgical resection. Following the July 5 announcement of topline results, detailed findings from the phase 3 CheckMate -238 study were highlighted during the ESMO 2017 Congress in Madrid, Spain.

Merck’s KEYTRUDA® (pembrolizumab) Continues to Show Overall Survival Benefit Over Chemotherapy with Nearly Two Years Follow-Up in Previously Treated Patients with Advanced Urothelial Carcinoma, Post-Platinum Failure

merck

September 10, 2017

Merck has announced updated results from the phase 3 KEYNOTE-045 trial evaluating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) with disease progression on or after platinum-containing chemotherapy (post-platinum failure). Updated data show that with median follow-up of 22.5 months, KEYTRUDA continues to demonstrate an overall survival (OS) benefit over investigator’s choice of paclitaxel, docetaxel or vinflunine as a second-line therapy, post-platinum failure, regardless of PD-L1 expression (HR, 0.70 [95% CI, 0.57-0.86], p=0.0003). Findings were presented at the ESMO 2017 Congress in Madrid, Spain.

Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial

bms-logo

September 10, 2017

Bristol-Myers Squibb Company has announced results from the Phase 3 CheckMate -214 trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC), including data on key subgroups. With a minimum follow-up of 17.5 months, Opdivo in combination with Yervoy reduced the risk of death 37% [HR 0.63; 99.8% CI: 0.44 to 0.89; P < 0.0001] compared with sunitinib, the current standard of care, in an interim analysis of overall survival (OS) in intermediate- and poor-risk patients, the co-primary endpoint. The median OS had not yet been reached for the combination and was 26 months for sunitinib (95% CI: 22.1 to NA). Results from CheckMate -214 were presented during Presidential Symposium II at the European Society for Medical Oncology (ESMO) 2017 Congress.

Abemaciclib Initial Therapy Improves Outcome in Endocrine-sensitive Advanced Breast Cancer

Eli Lilly Logo

September 10, 2017

The results of the MONARCH 3 trial by Eli Lilly, presented at the ESMO 2017 Congress, showed that adding the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib to endocrine therapy improved progression-free survival compared to endocrine therapy alone in the total study population. While most women had substantial benefit from the addition of abemaciclib as initial treatment, around one-third of women may not need a CDK 4/6 inhibitor as initial treatment.

Novartis Phase III study demonstrates adjuvant Tafinlar® + Mekinist® reduced the risk of disease recurrence by 53% in patients with resected BRAF V600 mutation-positive melanoma

Novartis logo - luca dezzaniSeptember 11, 2017

Novartis has announced results from a Phase III study of 870 patients with stage III BRAF V600E/K mutation-positive melanoma after complete surgical resection treated with the combination of Tafinlar® (dabrafenib) + Mekinist® (trametinib). Findings from the COMBI-AD study, which met its primary endpoint, found a statistically significant 53% reduction in the risk of death or recurrence in patients treated with the BRAF and MEK inhibitor combination therapy versus placebo (HR [hazard ratio]: 0.47 [95% CI (confidence interval): 0.39-0.58]; median not reached vs. 16.6 months, respectively; p<0.001), with no new safety signals reported. Results of the study were presented during the Presidential Symposium at ESMO.

Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma

roche1

September 11, 2017

Roche has announced data for the phase III BRIM8 study, which was designed to investigate the efficacy and safety of Zelboraf® (vemurafenib) in the adjuvant (after surgery) treatment of people with completely resected, BRAF V600 mutation-positive melanoma. The study assessed two cohorts; stage IIC-IIIB (cohort 1) and stage IIIC (cohort 2) melanoma patients. The study did not meet its primary endpoint of significantly reducing the risk of recurrence (disease-free survival; DFS) in patients with stage IIIC melanoma (cohort 2); however, a 46% reduction in recurrence risk was observed in stage IIC-IIIB patients (cohort 1). The safety profile was consistent with that seen in previous studies of Zelboraf in advanced melanoma.

Merck KGaA Advances Immunology Pipeline with Evobrutinib (Bruton’s Tyrosine Kinase Inhibitor)

merck kgaa

September 12, 2017

Merck, a leading science and technology company, has announced that it is continuing to advance its Immunology pipeline. Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor (BTKi) discovered by Merck, is now in Phase IIb studies across multiple immunological indications: rheumatoid arthritis (RA), multiple sclerosis (MS), and systemic lupus erythematosus (SLE).

 

FDA Approves Amgen And Allergan’s MVASI™ (bevacizumab-awwb) For the Treatment of Five Types of Cancer

amgen

September 14, 2017

Amgen and Allergan plc. have announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin® (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA. MVASI is approved for the treatment of five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix.

Pfizer And Astellas Announce Positive Top-Line Results from Phase 3 Prosper Trial of Xtandi (Enzalutamide) In Patients with Non-Metastatic Castration-Resistant Prostate Cancer

Pfizer logo

September 14, 2017

Pfizer Inc. and Astellas Pharma Inc. have announced that the Phase 3 PROSPER trial evaluating XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS). The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of XTANDI in previous clinical trials.

 

 

Bayer receives FDA approval for Copanlisib in adults with relapsed follicular lymphoma after two prior systemic therapies

Bayer Logo

September 14, 2017

Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved copanlisib under the brand name Aliqopa™ 60 mg vial for injection for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

New FOURIER Analysis Shows Repatha® (Evolocumab) Reduces Cardiovascular Events in Patients with Diabetes

amgen

September 15, 2017

Amgen has announced that a new analysis of the cardiovascular outcomes study (FOURIER) demonstrated that lowering low-density lipoprotein cholesterol (LDL-C) levels with Repatha® (evolocumab) significantly and consistently reduced cardiovascular events in patients with and without diabetes at baseline.

Phase III data showed that Venclexta/Venclyxto plus MabThera/Rituxan helped people with previously treated chronic lymphocytic leukaemia live longer without their disease worsening compared to bendamustine plus MabThera/Rituxan

roche1

September 18, 2017

Roche has announced that the phase III MURANO study, which evaluated Venclexta®/Venclyxto® (venetoclax) in combination with MabThera®/Rituxan® (rituximab) in people with relapsed or refractory chronic lymphocytic leukaemia (CLL), met its primary endpoint and showed a statistically significant improvement in the time people lived without their disease progressing (progression-free survival [PFS] as assessed by investigator) when treated with Venclexta/Venclyxto plus MabThera/Rituxan compared to bendamustine plus Mabthera/Rituxan.

Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD

AstraZeneca Logo

25 September 2017

AstraZeneca has announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) to patients with moderate to very severe chronic obstructive pulmonary disease (COPD). AstraZeneca will make regulatory filing applications for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously reported trials.

Sanofi and Regeneron Announce Approval of Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union

sanofi

 

September 28, 2017

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for Dupixent® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

You may also be interested in the following analyses and perspectives:

Medical Science Liaisons (MSL) and Investigator Initiated Studies: The Why, When, How and the So What

Medical Science Liaisons (MSL) and Investigator Initiated Studies: The Why, When, How and the So What

2 September 2017

Many MSLs are working on pipeline molecules and are therefore involved in clinical studies liaising with key opinion leaders (KOLs). Oftentimes these clinical studies are the company sponsored trials. However, MSLs are also the first point of contact to start discussing KOLs’ own clinical research study ideas using the company’s (pipeline) molecules. These KOLs’ investigator initiated studies are known by different acronyms in pharma/biotech: investigator initiated studies (IIS), investigator sponsored studies (ISS), investigator sponsored trials (IST) or externally sponsored research (ESR) to just name a few. We will call them IIS to clearly indicate they are investigator initiated, as an MSL is not allowed to proactively initiate an IIS discussion, as it is off-label.

The MSL Gender Pay Gap

The MSL Gender Pay Gap

12 September 2017

One question, that is coming up a lot in the media, is why there “seems” to be an imbalance in gender distribution in the workforce and more importantly a gender salary gap? We set out to analyze whether this was the case for MSLs, using our 2017 global MSL salary survey where we surveyed close to 600 MSLs in their local currency. Our salary survey data showed that there are large variations of female MSLs per countries, ranging from 71% in Belgium to 25% in India. Focusing on starting MSLs (0-2y MSL experience) we noticed a MSL gender salary gap of at least 10% in favor of male MSLs for the following countries: Brazil, Belgium, the Netherlands, Italy, Spain and the UK. In two of those countries the difference could be explained by male MSLs having worked (many) more years in pharma, however, leaving four countries with a true MSL gender salary gap.

Top 10 Pharmaceutical Companies 2017: Anti-Diabetics

Top 10 Pharmaceutical Companies 2017: Anti-Diabetics

 

17 September 2017

In 2016, the size of anti-diabetics market was $43.6bn. With its worldwide market share of 5.4%, anti-diabetics maintained its dominant position in the market of prescription drugs and OTC. Novo Nordisk still dominates the anti-diabetics market, with its global market share of 29.7% in 2016. In this year, Novo Nordisk earned $12.9bn by selling anti-diabetic products, mainly Victoza, NovoRapid, and Tresiba. With its popular GLP-1 Trulicity, Eli Lilly is also maintaining its leading position. In 2016, the global sales of Trulicity reached $926M, with 2.1% of worldwide market share.

Top 30 Oncology Drugs 2017

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23 September 2017

The global oncology market is expected to grow at a rate of 7.5% with top-ten companies accounting for more than one-third of the market share. Roche tops the list with three drugs in the high rankings accounting for nearly 45% of the revenues. Celgene’s Revlimid is the best-selling drug also showing a 20% growth rate from 2015. Interestingly, the top 10 oncology drugs revenue in 2016 is a 13% increase from 2015’s top 10 list revealing numerous market opportunities.

Top Pharma News | September – October 2017 last edit: 2017-10-08T18:32:46+00:00 da Luca

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