Blue Cross Blue Shield of Massachusetts to integrate PillPack into member app

Blue Cross Blue Shield of Massachusetts will integrate Amazon’s PillPack into its member app, making it the first health plan to offer this type of direct integration with the online pharmacy.

Members in fully-insured, commercial plans will have the option to switch to PillPack from Blue Cross’ MyBlue app or directly from the insurer’s website, the health plan announced this week. The target demographic is members who are taking multiple medications.

For those who choose to use PillPack’s services, they’ll be able to store their insurance and demographic information and medication lists, saving time when they need to order prescriptions, Blue Cross officials said.

“We know many of our members are managing daily medications, which can cause confusion and stress,” said Blue Cross CEO Andrew Dreyfus in a statement. “By making it easy to use PillPack, we are giving our members easy access to a simpler, more personalized experience that removes the guesswork from taking multiple prescriptions.”

Online retail giant Amazon purchased PillPack in July 2018, which has caused friction with legacy companies in the space, including Surescripts and CVS Health. CVS took its own prescription delivery service nationwide in August.

Members who choose to use PillPack will have access to customized dosage packaging, access to pharmacists around the clock, proactive contact with physicians to ensure there are no gaps in medication and routine monitoring for adverse effects, without an additional subscription fee, Blue Cross officials said.

“We hope this integration with PillPack will make it easy for our members to have a convenient way to manage their medications so they can go back to focusing on what’s important to them,” said Katie Catlender, vice president of consumer experience at the insurer, in a statement.

https://www.fiercehealthcare.com/payer/blue-cross-blue-shield-massachusetts-to-integrate-pillpack-into-member-app

Seattle Genetics hails ‘stunning’ tucatinib breast cancer data

Seattle Genetics has shared more of the tucatinib data it hopes will win it approval in HER2-positive breast cancer. The pivotal trial linked the tyrosine kinase inhibitor to reduced risk of progression and death in patients with and without brain metastases, leading Seattle Genetics CEO Clay Siegall to hail the data as “stunning.”

Investigators enrolled 612 women with locally advanced or metastatic HER2-positive breast cancer who had on average received four lines of prior therapy. The patients, close to half of whom had brain metastases, were no longer responding to Roche’s HER2 drugs Herceptin, Perjeta or Kadcyla.

In that hard-to-treat population, adding tucatinib to Herceptin and capecitabine was associated with a 46% reduction in the risk of disease progression or death over the backbone regimen alone. In the subgroup of patients with brain metastases, the reduction in risk of disease progression or death was bigger still at 52%. Seattle Genetics is happy with the results.

“Take those groups and you’ve about prevented about half of the progression and deaths and so it’s pretty stunning,” Siegall said at the American Society of Hematology (ASH) 2019 annual meeting.

Seattle Genetics went from ASH to the 2019 San Antonio Breast Cancer Symposium, where it shared detailed data from its pivotal tucatinib trial. The data add nuance to the headline results shared in October, revealing, for example, that the estimated progression-free survival for patients with brain metastases at one year was 25% in the tucatinib group and 0% in the control arm.

Despite the proliferation of drugs approved in HER2-positive breast cancer, the sizable subpopulation of patients with brain metastases remains underserved.

“The impact on the brain metastases associated with breast cancer was especially great to see because there’s not been any drugs that have shown efficacy in pre-existing brain metastases and that’s what’s unique about this,” Siegall said.

Puma Biotechnology is working to show Nerlynx, which is already approved, works in patients with brain metastases, picking up orphan drug status in the indication earlier this year. However, Nerlynx suffers from tolerability problems that may make it less appealing than tucatinib.

The FDA label for Nerlynx states 40% of people who received the drug in a pivotal trial suffered grade 3 diarrhea. In Seattle Genetics’ trial, 13% of patients on tucatinib had grade 3 diarrhea. At around 5%, the proportion of people on tucatinib with elevated liver enzymes was higher than in the Nerlynx trial. However, discontinuations due to elevated liver enzymes were rarer in the tucatinib trial.

Seattle Genetics plans to file for approval in the U.S. and Europe in the first quarter of 2020, although it is trying to pull that date forward and ensure patients can access the drug while it it is awaiting a regulatory decision.

“We’re working extremely hard and close with FDA to submit and we said we would submit as fast as we can, certainly by early next year at the latest. It’s just too important to get this done and out on the market. We are going to set up an expanded access plan until approval for patients in the U.S. because it’s a meaningful drug,” Siegall said.

Approval would further validate Seattle Genetics’ decision to buy Cascadian Therapeutics. Seattle Genetics paid more than $600 million to acquire Cascadian last year, in large part to get its hands on tucatinib. The deal moved Seattle Genetics beyond its focus on antibody-drug conjugates and gave it another late-phase solid tumor prospect.

https://www.fiercebiotech.com/biotech/sabcs-seattle-genetics-hails-stunning-tucatinib-breast-cancer-data

Sanofi CEO turns to ‘cobots’ and AI to zap manufacturing costs

Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean heavily on that strategy to shrink costs and fatten margins. Using robotics, artificial intelligence and new generation manufacturing should save it half a billion euros in annual costs by 2022.

So says Sanofi CFO Jean-Baptiste Chasseloup de Chatillon who was filling in some details of new CEO Paul Hudson’s €2 billion cost-savings plan laid out Tuesday during Sanofi’s investor conference.

“It is a leapfrogging of productivity. It reduces cycle time,” Chasseloup de Chatillon said on a webcast of the conference.

And by how much. According to the company, by speeding up its plant revamps to digitized processes, it expects to reduce lead times by 6 months, while a shift to what it calls second-generation processes in vaccines and biologics will cut cycle times by 20%.

Additionally, new digital processes and AI forecasting for its supply chain is forecast to cut inventory levels by 20 days, while “optimizing” its contract suppliers will reduce the baseline costs there by 20%

Sanofi is incorporating digital processes into all of the new biologics plants that it is building but decided to retrofit its key biologics plants in Framingham, Massachusetts and Geel, Belgium to use the cutting-edge processes. It has invested more than $300 million in Framingham to retrofit it for the future.

The new operations use collaborative robots, or “cobots,” that work next to humans for some processes, and autonomous mobile robots that can travel along digital pathways to deliver ingredients and equipment. Processes in Framingham are all paperless, and its flexible facility design allows much of the same equipment to function for a variety of products.

More robots also means there is a need for fewer people. It cut 95 jobs there last year, even as the upgrades allowed for greater capacity.

Manufacturing savings is only one part of the cost-cutting puzzle. Hudson also says the company will eliminate jobs in support functions, tighten up purchasing and reduce travel.

https://www.fiercepharma.com/manufacturing/sanofi-ceo-turns-to-cobots-and-ai-to-shave-manufacturing-costs

Aprea Phase Ib/II Leukemia Results at ASH19

• 88% ORR, 61% CR rate by IWG criteria in 33 evaluable MDS patients
• 8.4 months median duration of response, with 7.3 months median duration of CR in evaluable MDS patients
• 52% of evaluable MDS patients discontinued treatment for stem cell transplant

Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented results at the 2019 ASH Annual Meeting from its U.S. Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutated MDS and AML. The clinical trial is sponsored by the Moffitt Cancer Center with financial support from the MDS Foundation and the Aplastic Anemia and MDS International Foundation as administrator for the Evans MDS Clinical Research Consortium.

As of the data cutoff, the overall response rate (ORR) in 33 evaluable MDS patients was 88%, with a 61% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 10.8 months, the median duration of response was 8.4 months and the median duration of CR was 7.3 months. Seventeen (52%) evaluable MDS patients discontinued therapy to pursue stem cell transplant. Median overall survival (OS) for all enrolled patients (n=55) was 10.8 months. Median OS in responding patients versus non-responders was 13.7 vs. 3.9 months. Adverse events, regardless of causality, were mostly grade 1/2. Grade 3+ adverse events occurring in ≥20% of patients were limited to cytopenias and infection, consistent with underlying hematopoietic malignancies, and no exacerbation of the expected AZA-related safety profile has been observed.

http://www.globenewswire.com/news-release/2019/12/09/1958041/0/en/Aprea-Therapeutics-Presents-Results-From-U-S-Phase-Ib-II-Clinical-Trial-of-APR-246-and-Azacitidine-AZA-in-Patients-with-TP53-Mutant-Myelodysplastic-Syndromes-MDS-and-Acute-Myeloid-.html

Genetic Tech up 22% on pending launch of breast cancer test

Thinly traded nano cap Genetic Technologies Limited (GENE +21.6%) is up on almost a 5x surge in volume, albeit on turnover of only 149K shares, in response to its announcement that sales of its third-generation breast cancer test should commence next quarter.

The company aims to set up 12 clinical sites to demonstrate utility, user experience, reimbursement and distribution.

The test, called Genetype for Breast Cancer, predicts the risk of disease by combining DNA and mammography data.

https://seekingalpha.com/news/3525576-genetic-tech-up-22-on-pending-launch-of-breast-cancer-test

MacroGenics down 3% on uncertainty of margetuximab survival benefit

MacroGenics (MGNX -2.9%) is down on double normal volume in response to results from a second interim survival analysis of Phase 3 clinical trial, SOPHIA, comparing lead drug margetuximab + chemo to Roche’s Herceptin (trastuzumab) + chemo in patients with HER2-positive metastatic breast cancer who have previously received anti-HER2-targeted therapies. The data were presented at the San Antonio Breast Cancer Symposium.

Overall survival (OS) favored margetuximab, but the separation was not statistically significant. Specifically, median OS was 21.6 months versus 19.8 months for trastuzumab (p=0.326) (first reported in October). The final OS analysis will be based on 385 events, expected to occur in H2 2020.

The company says that margetuximab showed a statistically valid improvement in progression-free survival, although the median value (5.8 months) was only a few weeks better than trastuzumab (4.9 months) (p=0.033).

https://seekingalpha.com/news/3525585-macrogenics-down-3-on-uncertainty-of-margetuximab-survival-benefit

FDA clears new bone conduction implant from Cochlear

The FDA grants 510(k) clearance to Cochlear Limited’s (OTCPK:CHEOF) Osia 2 System, an osseointegrated steady-state bone conduction implant that stimulates the inner ear to improve hearing in people at least 12 years old with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness.

The device will be initially available in select U.S. clinics under limited release. Full commercial availability will happen in next quarter.

https://seekingalpha.com/news/3525591-fda-clears-new-bone-conduction-implant-from-cochlear