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Posts Tagged ‘Keytruda (pembrolizumab)’


Live Conference Coverage @Medcitynews Converge 2018 @Philadelphia: Promising Drugs and Breaking Down Silos

Reporter: Stephen J. Williams, PhD

Promising Drugs, Pricing and Access

The drug pricing debate rages on. What are the solutions to continuing to foster research and innovation, while ensuring access and affordability for patients? Can biosimilars and generics be able to expand market access in the U.S.?

Moderator: Bunny Ellerin, Director, Healthcare and Pharmaceutical Management Program, Columbia Business School
Speakers:
Patrick Davish, AVP, Global & US Pricing/Market Access, Merck
Robert Dubois M.D., Chief Science Officer and Executive Vice President, National Pharmaceutical Council
Gary Kurzman, M.D., Senior Vice President and Managing Director, Healthcare, Safeguard Scientifics
Steven Lucio, Associate Vice President, Pharmacy Services, Vizient

What is working and what needs to change in pricing models?

Robert:  He sees so many players in the onStevencology space discovering new drugs and other drugs are going generic (that is what is working).  However are we spending too much on cancer care relative to other diseases (their initiative Going Beyond the Surface)

Steven:  the advent of biosimilars is good for the industry

Patrick:  large effort in oncology, maybe too much (750 trials on Keytruda) and he says pharma is spending on R&D (however clinical trials take large chunk of this money)

Robert: cancer has gotten a free ride but cost per year relative to benefit looks different than other diseases.  Are we overinvesting in cancer or is that a societal decision

Gary:  maybe as we become more specific with precision medicines high prices may be a result of our success in specifically targeting a mutation.  We need to understand the targeted drugs and outcomes.

Patrick: “Cancer is the last big frontier” but he says prices will come down in most cases.  He gives the example of Hep C treatment… the previous only therapeutic option was a very toxic yearlong treatment but the newer drugs may be more cost effective and safer

Steven: Our blockbuster drugs could diffuse the expense but now with precision we can’t diffuse the expense over a large number of patients

President’s Cancer Panel Recommendation

Six recommendations

  1. promoting value based pricing
  2. enabling communications of cost
  3. financial toxicity
  4. stimulate competition biosimilars
  5. value based care
  6. invest in biomedical research

Patrick: the government pricing regime is hurting.  Alot of practical barriers but Merck has over 200 studies on cost basis

Robert:  many concerns/impetus started in Europe on pricing as they are a set price model (EU won’t pay more than x for a drug). US is moving more to outcomes pricing. For every one health outcome study three studies did not show a benefit.  With cancer it is tricky to establish specific health outcomes.  Also Medicare gets best price status so needs to be a safe harbor for payers and biggest constraint is regulatory issues.

Steven: They all want value based pricing but we don’t have that yet and there is a challenge to understand the nuances of new therapies.  Hard to align all the stakeholders together so until some legislation starts to change the reimbursement-clinic-patient-pharma obstacles.  Possibly the big data efforts discussed here may help align each stakeholders goals.

Gary: What is the data necessary to understand what is happening to patients and until we have that information it still will be complicated to determine where investors in health care stand at in this discussion

Robert: on an ICER methods advisory board: 1) great concern of costs how do we determine fair value of drug 2) ICER is only game in town, other orgs only give recommendations 3) ICER evaluates long term value (cost per quality year of life), budget impact (will people go bankrupt)

4) ICER getting traction in the public eye and advocates 5) the problem is ICER not ready for prime time as evidence keeps changing or are they keeping the societal factors in mind and they don’t have total transparancy in their methodology

Steven: We need more transparency into all the costs associated with the drug and therapy and value-based outcome.  Right now price is more of a black box.

Moderator: pointed to a recent study which showed that outpatient costs are going down while hospital based care cost is going rapidly up (cost of site of care) so we need to figure out how to get people into lower cost setting

Breaking Down Silos in Research

“Silo” is healthcare’s four-letter word. How are researchers, life science companies and others sharing information that can benefit patients more quickly? Hear from experts at institutions that are striving to tear down the walls that prevent data from flowing.

Moderator: Vini Jolly, Executive Director, Woodside Capital Partners
Speakers:
Ardy Arianpour, CEO & Co-Founder, Seqster @seqster
Lauren Becnel, Ph.D., Real World Data Lead for Oncology, Pfizer
Rakesh Mathew, Innovation, Research, & Development Lead, HealthShareExchange
David Nace M.D., Chief Medical Officer, Innovaccer

Seqster: Seqster is a secure platform that helps you and your family manage medical records, DNA, fitness, and nutrition data—all in one place. Founder has a genomic sequencing background but realized sequence  information needs to be linked with medical records.

HealthShareExchange.org :

HealthShare Exchange envisions a trusted community of healthcare stakeholders collaborating to deliver better care to consumers in the greater Philadelphia region. HealthShare Exchange will provide secure access to health information to enable preventive and cost-effective care; improve quality of patient care; and facilitate care transitions. They have partnered with multiple players in healthcare field and have data on over 7 million patients.

Innovacer

Data can be overwhelming, but it doesn’t have to be this way. To drive healthcare efficiency, we designed a modular suite of products for a smooth transition into a data-driven world within 4 weeks. Why does it take so much money to move data around and so slowly?

What is interoperatibility?

Ardy: We knew in genomics field how to build algorithms to analyze big data but how do we expand this from a consumer standpoint and see and share your data.

Lauren: how can we use the data between patients, doctors, researchers?  On the research side genomics represent only 2% of data.  Silos are one issue but figuring out the standards for data (collection, curation, analysis) is not set. Still need to improve semantic interoperability. For example Flatiron had good annotated data on male metastatic breast cancer.

David: Technical interopatabliltiy (platform), semantic interopatability (meaning or word usage), format (syntactic) interopatibility (data structure).  There is technical interoperatiblity between health system but some semantic but formats are all different (pharmacies use different systems and write different prescriptions using different suppliers).  In any value based contract this problem is a big issue now (we are going to pay you based on the quality of your performance then there is big need to coordinate across platforms).  We can solve it by bringing data in real time in one place and use mapping to integrate the format (need quality control) then need to make the data democratized among players.

Rakesh:  Patients data should follow the patient. Of Philadelphia’s 12 health systems we had a challenge to make data interoperatable among them so tdhey said to providers don’t use portals and made sure hospitals were sending standardized data. Health care data is complex.

David: 80% of clinical data is noise. For example most eMedical Records are text. Another problem is defining a patient identifier which US does not believe in.

 

 

 

 

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Immuno-Therapy Strategies on BioMarker’s cutoff value for defining PD-L1 positive/negative patients: First-line and Second-line setting – FDA stand on BMS’s “Test-free Prescribing” in Opdivo (nivolumab) vs Merck’s “Companion Diagnostic” in Keytruda (pembrolizumab) vs Genetech’s “Complementary Diagnostics” and”Companion Diagnostic”?? in Tecentriq (atezolizumab)

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on May 1, 2018

Dive Insight:

While both Keytruda and Opdivo won initial U.S. approval just months apart in 2014, Bristol-Myers’ drug saw much faster sales growth to start. Securing OKs in first-line lung cancer has been Merck’s ticket to catching Bristol-Myers, and Keytruda sales in the first quarter were roughly even with Opdivo’s.

Merck expects the success of its KEYNOTE-189 study will further drive uptake of Keytruda as a first-line treatment for advanced NSCLC. Results, presented last month at the annual meeting of the American Association of Cancer Research, showed a combination of Keytruda and chemotherapy cut the risk of death in half compared to chemotherapy alone.

Importantly, data supported the combination’s benefit across varying levels of PD-L1 expression , a biomarker used to identify patients most likely to respond to immunotherapy. Merck previously won a conditional approval for the combo from a smaller study, but physicians have been hesitant to broadly prescribe without further data.

Now, impressive results in hand, Merck hopes more doctors will prescribe Keytruda plus chemotherapy to NSCLC patients with PD-L1 expression levels below 50% or even below 1% — patient populations currently not served by Keytruda monotherapy.

SOURCE

https://www.biopharmadive.com/news/merck-keytruda-immunotherapy-lead-q1-earnings-pipeline/522513/

UPDATED on 3/26/2018

Gaining steam in PD-1/L1 race, Roche reports positive PhIII OS data on Tecentriq combo in NSCLC

by brittany meiling — on March 26, 2018 06:29 AM EDT

https://endpts.com/gaining-steam-in-pd-1-l1-race-roche-reports-positive-phiii-os-data-on-tecentriq-combo-in-nsclc/?utm_medium=email&utm_campaign=Monday%20March%2026%202018&utm_content=Monday%20March%2026%202018+CID_12d9cbde6620f32af9d31d31236c94c4&utm_source=ENDPOINTS%20emails&utm_term=Gaining%20steam%20in%20PD-1L1%20race%20Roche%20reports%20positive%20PhIII%20OS%20data%20on%20Tecentriq%20combo%20in%20NSCLC

 

UPDATED on 3/20/2018

In a phase 3 study, Roche’s Tecentriq combined with chemo beat out solo chemo at cutting the risk of disease worsening or death in previously untreated patients with the squamous form of the disease. As of now, researchers haven’t seen evidence of a benefit to overall survival, but the trial, dubbed IMpower131, is continuing to collect that data.

The results hand Roche the chance to nab a first-to-market lead in the front-line squamous setting. Squamous NSCLC affects just 25% to 30% of all NSCLC patients, but it’s more complicated, and patients have fewer treatment options than those with non-squamous NSCLC, Jefferies analyst Ian Hilliker wrote in a note to clients. Hilliker predicts $1.1 billion in peak sales for Tecentriq in that set of patients.

SOURCE

https://www.fiercepharma.com/pharma/roche-s-tecentriq-triumphs-squamous-lung-cancer-can-it-make-its-mark-against-merck?mkt_tok=eyJpIjoiTlRrM09UQTFNVFEzTjJRNCIsInQiOiJNUnhJMThFZGw5ZERKS1N3Q3dQbGg2dmE1NHhTSFhYZjcycVdMcTAwaTZ1cWxZV3ZJQStqZXJZb0lJUkowNmdXZVk1dnFCc1hVVUlSZitWZ2pPMlJYc25VUXVXY0JxeDdYbUw2XC9uOHgzYWNFb3lObGhrTXd6T25IRWFoTTZTZXcifQ%3D%3D&mrkid=993697

 

UPDATED on 11/21/2017

Roche Cancer Drug Rises To Challenge Merck, Bristol-Myers

Roche’s study had three arms. All patients received carboplatin and paclitaxel, the cancer drug once sold as Taxol. The control group also received Avastin, one of Roche’s best-selling cancer drugs. Then two groups got Tecentriq, one with Avastin and one without. What Roche has announced today is that the Avastin-Tecentriq-chemotherapy combination did better than Avastin and chemotherapy alone, and that the survival results so far are “encouraging.” That leaves a big question: how are the patients who got Tecentriq, but not Avastin, doing?

SOURCE

https://www.forbes.com/sites/matthewherper/2017/11/20/roche-cancer-drug-rises-to-challenge-merck-bristol-myers/#1a08271b52a8

 

UPDATED on 7/25/2017

Close to a year after Merck $MRK won an accelerated FDA OK to use its PD-1 checkpoint star Keytruda for treating second-line cases head and neck squamous cell carcinoma in combination with platinum-containing chemo, the pharma giant announced that its big Phase III study for that indication failed.

The pivotal KEYNOTE-040 trial failed to meet the primary endpoint on overall survival in comparing the blockbuster checkpoint against standard therapies, the pharma giant reported. But the current approval stands nevertheless, Merck said in a statement.

“The company noted that the FDA remains comfortable with the drug’s current accelerated approval in this indication despite the trial results,” observed Leerink’s Seamus Fernandez. “Importantly, Keytruda appears to have another shot on goal for full approval in H&N cancer, as the Keynote-048 study in first-line patients could, if positive, serve as the confirmatory trial.”

SOURCE

https://endpts.com/merck-hit-with-another-late-stage-setback-on-checkpoint-star-keytruda/?utm_medium=email&utm_campaign=Tuesday%20%20July%2025%202017&utm_content=Tuesday%20%20July%2025%202017+CID_15fd9125b2763ceaf79f421345542d44&utm_source=ENDPOINTS%20emails&utm_term=Merck%20hit%20with%20another%20late-stage%20setback%20on%20checkpoint%20star%20Keytruda

UPDATED on 5/11/2017

Merck increases grip on its lead in lung cancer, winning approval for Keytruda/chemo combo as first-line therapy

UPDATED on 5/10/2017

Roche’s shocking Tecentriq fail raises red flag for bladder cancer rivals

Roche’s Tecentriq wasn’t supposed to fail its phase 3 trial in second-line bladder cancer. But that’s what it just did—and the data shortfall not only endangers the drug’s conditional FDA approval, but could augur trouble ahead for other checkpoint inhibitors that followed Tecentriq into the field.

Tecentriq, approved last year on the basis of phase 2 data showing a durable response to the drug, failed to prove it could actually prolong patients’ lives, the company said Wednesday. The bladder cancer indication, Tecentriq’s first, accounts for about 70% of the med’s current sales, analysts say, and the FDA could well decide to strike that approval off the drug’s label.

“[W]e assume that this will put this indication at risk of being removed from the label,” Leerink analyst Seamus Fernandez wrote Wednesday morning, noting that the results were unexpected. “This comes as a surprise to us, considering Merck’s Keytruda showed an overall survival benefit.”

SOURCE

http://www.fiercepharma.com/pharma/roche-s-shocking-tecentriq-fail-raises-red-flag-for-bladder-cancer-rivals?utm_medium=nl&utm_source=internal&mrkid=993697&mkt_tok=eyJpIjoiTVRCbFltUXpZMk0wTURRMCIsInQiOiIydnRsZ0xzT3prd3EzYVNoV0xyT1ZCWnFCaDFScVdwd1dyMmpMZjQycU9zOEVJSTVZalY5dHNyQ1E0XC96eXhadkpRSE5JRGoydHNzNFA2WUVaRzRVbUxmNmhicVZ4YkE3c1NmNkhoSUxBK0VmU2dUM3FBWEhrOFp2UHoySXhrUUEifQ%3D%3D

UPDATED on 4/13/2017

World’s Top Ten Cancer Drugs by 2020  (million USD)

https://pharmaceuticalintelligence.com/2017/04/13/worlds-top-ten-cancer-drugs-by-2020-million-usd/

Opdivo Setback May Yield Lessons for Pharma Advancing Immunotherapies With PD-L1 Testing

https://www.genomeweb.com/molecular-diagnostics/opdivo-setback-may-yield-lessons-pharma-advancing-immunotherapies-pd-l1

UPDATED on 10/9/2016

Opdivo (nivolumab) Shows Durable Response in Longest Follow-up for a PD-1 Inhibitor in Previously Treated Advanced Non-Small Cell Lung Cancer

BMY

Opdivo (nivolumab) Shows Durable Response in Longest Follow-up for a PD-1 Inhibitor in Previously Treated Advanced Non-Small Cell Lung Cancer

Updated data from CheckMate -057 and -017 show Opdivo-treated patients had tripled the duration of response compared to those treated with docetaxel, with a minimum follow-up of two years

In CheckMate -057, durable responses and complete responses were observed with Opdivo in both PD-L1 expressors and non-expressors

Patient-reported outcomes from CheckMate -057 show favorable overall health status with Opdivo versus docetaxel in previously treated advanced non-small cell lung cancer patients

Bristol-Myers Squibb Company (NYSE: BMY) announced today updated results from two pivotal Phase 3 studies, CheckMate -057 and CheckMate -017, which showed more than one-third of previously treated metastatic non-small cell lung cancer (NSCLC) patients in both trials experienced ongoing responses with Opdivo, compared to no ongoing responses in the docetaxel arm. The median duration of response (DOR) with Opdivo versus docetaxel in CheckMate -057 was 17.2 months (95% CI: 8.4, NE) and 5.6 months (95% CI: 4.4, 6.9), respectively, and in CheckMate -017 it was 25.2 months (95% CI: 9.8, 30.4) and 8.4 months (95% CI: 8.4, NE), respectively. In CheckMate -057, patients with PD-L1 ≥1% had a median DOR of 17.2 months (95% CI: 8.4, NE) and in patients with PD-L1 <1%, it was 18.3 months (95% CI: 5.5, NE). In both studies, durability of response was observed in both PD-L1 expressors and non-expressors, and in CheckMate -057, one out of the four complete responses occurred in a patient with <1% PD-L1 expression.

There were no new safety signals identified for Opdivo in the pooled safety analysis from both studies. No new treatment-related deaths occurred between one and two years’ minimum follow-up despite the longer treatment exposure, and new events were observed in 11/418 patients with an additional one year of follow up.

These findings were presented today, October 9, during a poster discussion session at the 2016 European Society for Medical Oncology Congress from 3:46-4:06 p.m. CEST (Abstract #1215PD).

“Further evaluation of Opdivo in previously treated non-small cell lung cancer showed continued superior survival and the potential for durable responses compared to docetaxel across histologies in this patient population,” said Martin Reck, M.D., Ph.D., head of thoracic oncology at the Hospital Grosshansdorf. “Notably, the median duration of response with Opdivo was more than three times that observed with docetaxel.”

Read more at

http://www.stockhouse.com/news/press-releases/2016/10/09/opdivo-nivolumab-shows-durable-response-in-longest-follow-up-for-a-pd-1#QVs566rlK9JKSMC8.99

UPDATED on 9/25/2016

Genentech dives into mRNA, betting $310M on BioNTech’s personalized cancer vaccine tech

For a review of all the complexities involved in the emerging market for BioMarkers in Immuno-Therapy, see

Opdivo Setback May Yield Lessons for Pharma Advancing Immunotherapies With PD-L1 Testing

https://www.genomeweb.com/molecular-diagnostics/opdivo-setback-may-yield-lessons-pharma-advancing-immunotherapies-pd-l1

PD-L1 testing as part of the tumor profiling workup for patients. Diaceutics’ surveys show a sharp uptick in the number of labs offering PD-L1 testing over the past year-and-a-half and 52 labs in the US offer at least one PD-L1 test. The company also reviewed biomarkers being studied in 95 Phase II/III NSCLC, and found that approximately half are incorporating patients’ PD-L1 status either alone or in combination with other markers, such as EGFR and ALK mutations.

At Cancer Genetics over the past year, there has also been a notable ramp up in orders for PD-L1 testing for lung cancer patients, but also for melanoma and head and neck cancer patients.

Labs are also challenged by having to decide whether to invest in validating and offering all four FDA-approved PD-L1 tests. “If you look from a laboratory perspective, in the ideal world, you need one test, and clear instructions about the algorithm and cutoff values to assign patients to treatment,” Braendle said. “Four different tests creates quite a confusing situation for the labs and the physicians.”

SOURCES

Diaceutics Group Report Reveals Significant Real-Time PD-L1 Testing Gaps in the US

http://www.diaceutics.com/diaceutics-group-report-reveals-significant-real-time-pd-l1-testing-gaps-in-the-us-3/

 

Opdivo Setback May Yield Lessons for Pharma Advancing Immunotherapies With PD-L1 Testing

https://www.genomeweb.com/molecular-diagnostics/opdivo-setback-may-yield-lessons-pharma-advancing-immunotherapies-pd-l1

 

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