Veracyte Demonstrates ‘Real World' Performance in Thyroid Cancer Diagnosis

Study findings reported at the American Thyroid Association Annual Meeting

Veracyte, Inc. (Nasdaq: VCYT) announced today that new findings from six studies reinforcing the “real world” performance of the next-generation Afirma Genomic Sequencing Classifier (GSC) and the Afirma Xpression Atlas in thyroid cancer diagnosis were presented at the 88^th Annual Meeting of the American Thyroid Association (ATA). The meeting is being held October 3-7 in Washington, D.C.

Researchers from leading institutions presented posters showing that use of the Afirma GSC at their respective centers significantly increased the identification of benign thyroid nodules among those deemed indeterminate – not clearly benign or malignant – following cytopathology review, compared to the original Afirma test.

• The Ohio State University – Researchers compared results of 113 indeterminate samples that were tested with the Afirma GSC to those of 403 samples using the earlier version of the test (the Afirma Gene Expression Classifier, or GEC). The Afirma GSC identified 74.1 percent of the nodules as benign, compared to 48.4 percent with the GEC, an increase of 53 percent. The overall surgery rate among all patients who underwent genomic testing decreased by more than half – from 42.2 percent with the GEC to 20.2 percent with the GSC.
• Cleveland Clinic – Comparing results of 46 samples tested with the Afirma GSC between July 2017 and December 2017 with 182 samples tested with the original test between December 2011 and July 2017, researchers found that the GSC identified 67.4 percent as benign, compared to 41.8 percent with the GEC – an increase of 61 percent. The overall surgery rate for nodules tested with the GSC was 32.6 percent, compared to 47.3 percent with the original test, a decrease of 31 percent.
• Brigham and Women’s Hospital – Researchers evaluated results for 583 thyroid nodules tested with either the Afirma GSC (n=97) or GEC (n=486) between 2011 and 2018. They found that the Afirma GSC identified 64.9 percent of nodules as benign, compared to 47.9 percent with the GEC, an increase of 35 percent.

“Our results show that with the improved testing, we sent significantly fewer patients to surgery,” said Dr. Christian Nasr, medical director of the Thyroid Center in the Endocrinology & Metabolism Institute at Cleveland Clinic in Cleveland, Ohio. “Additionally, when patients went to surgery following ‘suspicious’ results, we were more likely to find cancer. Our findings suggest that the next-generation test can help more patients avoid unnecessary thyroid surgery, while focusing healthcare resources on the patients who are more likely to need them.”

Additionally, in two oral presentations, researchers shared the first “real world” Afirma Xpression Atlas data, providing insights into the distribution of a wide range of gene variants and fusions across key categories of indeterminate thyroid nodules and Afirma GSC results. For example, among 13,549 indeterminate thyroid nodules evaluated using the Afirma GSC and Xpression Atlas, more than a quarter (25.9 percent) of GSC-suspicious nodules (in primary risk categories known as Bethesda III/IV) contained RAS variants. Additionally, RET, NTRK, BRAF and ALK fusions were only found in GSC-suspicious, versus GSC-benign, cases (in all Bethesda categories).

https://www.biospace.com/article/releases/veracyte-announces-that-new-data-from-multiple-studies-demonstrate-real-world-performance-of-afirma-gsc-and-xpression-atlas-in-thyroid-cancer-diagnosis/

Blueprint Medicines Updates on Phase 1 Thyroid Cancer Trial Data

90 percent of evaluable MTC and PTC patients had tumor reductions
62 percent response rate in MTC patients treated with 300 to 400 mg once daily for at least 24 weeks
Patients with longest treatment durations remain on therapy for more than 15 months   

Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced the presentation of updated data from the ongoing Phase 1 ARROW clinical trial of BLU-667, an investigational precision therapy targeting RET alterations, including resistance mutations. The new results showed that BLU-667 was highly active and well-tolerated in patients with advanced RET-altered medullary thyroid cancer (MTC) and papillary thyroid cancer (PTC), with increased activity observed with higher dose levels and longer treatment durations.

The reported data showed 90 percent of evaluable patients with MTC and PTC had radiographic tumor reductions, regardless of RET alteration type or prior multi-kinase inhibitor (MKI) therapy. In addition, the response rate was 62 percent in patients with MTC treated once daily (QD) with BLU-667 at doses of 300 to 400 mg for at least 24 weeks. In the MTC and PTC populations, all responders across dose levels and all patients treated at 400 mg QD remain on study. Safety results were consistent with prior data, and the majority of adverse events (AEs) were Grade 1. These results were as of a data cutoff date of September 14, 2018 and were reported today in an oral presentation at The 88th Annual Meeting of the American Thyroid Association (ATA).

“Existing treatment of medullary and papillary thyroid cancer with multi-kinase inhibitors is limited by frequent dose modifications or interruptions due to off-target toxicities, reducing the opportunity for a meaningful or sustained response,” said Andy Boral, M.D., Ph.D., Chief Medical Officer of Blueprint Medicines. “These new data showed selectively targeting RET alterations with BLU-667 was well-tolerated and enabled durable responses. Importantly, response rates were high for patients with prolonged time on therapy at higher dose levels, demonstrating that potent and sustained target inhibition leads to improved patient outcomes. We believe these results begin to reveal the potential of BLU-667 to transform the care of patients with RET-altered thyroid cancer, and we look forward to seeing the data continue to mature as additional patients are treated at the recommended phase 2 dose for longer durations.”

Based on the encouraging data reported to date, Blueprint Medicines has expanded enrollment targets for the ARROW trial to further evaluate the safety and efficacy of BLU-667 in a broader patient population and, ultimately, to support potential registration.

https://www.biospace.com/article/releases/blueprint-medicines-announces-updated-data-from-phase-1-arrow-clinical-trial-showing-broad-durable-activity-of-blu-667-in-advanced-ret-altered-medullary-and-papillary-thyroid-cancers/

Genomics England Taps Iqvia for Clinical-Genomic Data Integration

 Genomics England is teaming with analytics firm Iqvia to develop a platform for bringing together clinical and genomic data in support of evidence-based precision medicine and drug discovery.

Under a deal announced today, Durham, North Carolina-based Iqvia — formerly known as Quintiles IMS — will offer its E360 analytics technology to authorized users of Genomics England’s database of de-identified genomic and phenotypic records. The British genomics program said that the partnership will strengthen the UK’s position as a global life sciences hub.

After the integrated genomic-clinical build of E360 goes online in 2019, Iqvia and Genomics England expect to serve academic and commercial researchers alike in genotype-phenotype association studies, comparative efficacy and safety trials, and burden-of-illness analytics.

“Our collaboration advances the analysis of these complex datasets, which could accelerate the discovery of precision therapies [and] improve access and health outcomes,” Jon Resnick, president of Iqvia Real-World and Analytics Solutions, said in a statement.

“Working together, we can unlock the potential of these datasets to advance research and benefit patients in the UK as well as those throughout the world,” added Genomics England Chief Commercial Officer Joanne Hackett.

https://www.genomeweb.com/informatics/genomics-england-taps-iqvia-clinical-genomic-data-integration#.W7shqNdKjIU

B.Riley/FBR Upgrades Assembly Biosciences (ASMB) to Buy

B.Riley/FBR analyst Madhu Kumar upgraded Assembly Biosciences (NASDAQ: ASMB) from Neutral

https://www.streetinsider.com/Analyst+Comments/B.RileyFBR+Upgrades+Assembly+Biosciences+%28ASMB%29+to+Buy/14682205.html

Lilly Gains on Upbeat Drug Data and an Upgrade

Eli Lilly stock is trading higher Friday, after touching all-time highs Thursday on positive data about its diabetes drug Empagliflozin, on the heels of positive analyst commentary.

Where we were: Eli Lilly is up nearly 36% since the start of the year, and got a boost from a trial that showed Empagliflozin met its primary end points.

Where we’re headed: Analysts are bullish on the stock’s ability to keep outperforming.

On Thursday, Eli Lilly (LLY) rose to an all-time intraday high (even though it did slip from them by the close) after the diabetes data. The stock saw more gains Friday, following an upgrade from BMO Capital Markets.

Analyst Alex Arfaei upgraded Eli Lilly to Outperform from Market Perform, with a $130 price target, writing that he’s more confident in company’s portfolio of drugs. He expects that Eli Lilly’s GLP-1 class of diabetes drugs will notch a compounded annual growth rate of 15% between this year and 2027, and that its Trulicity diabetes franchise can reach $11 billion in sales, which should help expand margins.

Arfaei is also bullish on pain drug Tanezumab, developed with Pfizer (PFE), and argues that investors aren’t assigning much value to Eli Lilly’s Alzheimer’s franchise. That makes the stock attractive, even with its year-to-date rally, he argues.

Nor is he the only analyst who likes Eli Lilly’s prospects. JPMorgan’s Chris Schott reiterated an Overweight rating and raised his price target on Eli Lilly to $123 from $117 Friday. He cites the upbeat diabetes data for his estimate increase, and writes that the stock “remains one of our favorite names in the group.”

He believes that the data suggest potentially a “best-in-class” profile for the drug, and it could become a multi-billion dollar product. Schott too believes that the stock can keep climbing despite its year-to-date run, given that Eli Lilly can generate mid-single digit sales growth and a low-teen earnings per share compound annual growth rate for “much of the next decade.”

Eli Lilly is up 1.7% to $114.89, while the SPDR S&P Pharmaceuticals ETF(XPH) is down 0.2% to $45.92, and the Health Care Select Sector SPDR ETF(XLV) is down 0.2% to $94.24.

https://www.barrons.com/articles/eli-lilly-stock-is-climbing-on-upbeat-drug-data-and-an-upgrade-1538768801

Novartis in FDA, EMA filing acceptance of MS med application

Novartis International AG / Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• There is a critical need for safe and effective treatments for secondary progressive multiple sclerosis (SPMS) – a highly debilitating form of MS characterized by gradual, irreversible worsening of disability, largely independent of relapses 
• If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression and expand possibilities for SPMS patients 
• Filings are supported by Phase III EXPAND data, which showed siponimod had beneficial effects on disability, relapses and magnetic resonance imaging (MRI) disease activities in typical SPMS patients[1]
• Novartis used a priority review voucher to expedite review of siponimod in the US to ensure patients could benefit from the drug as soon as possible, pending approval.

https://www.marketscreener.com/NOVARTIS-9364983/news/Novartis-announces-FDA-and-EMA-filing-acceptance-of-siponimod-the-first-and-only-drug-shown-to-me-27383634/

Alnylam’s Onpattro highly efficacious, safer than competitor, says Piper Jaffray

Piper Jaffray analyst Edward Tenthoff notes that Ionis Pharmaceuticals (IONS) announced FDA approval of TEGSEDI for treatment of hATTR polyneuropathy. The analyst also points out that the label includes a Black Box warning for thrombocytopenia and glomerulonephritis requiring every 2-week monitoring, and will be marketed by Ionis subsidiary Akcea (AKCA) with a Risk Evaluation and Mitigation Strategy. TEGSEDI is administered subcutaneously every week versus Alnylam’s (ANLY) ONPATTRO intravenously every 3 weeks with steroids, he adds. Tenthoff believes that ONPATTRO appears safer and highly efficacious, and should win out. The analyst reiterates an Overweight rating and $160 price target on Alnylam shares.

https://thefly.com/landingPageNews.php?id=2800682