On July 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an independent, systematic review and meta-analysis demonstrating that its DecisionDx-Melanoma test is a significant predictor of recurrence and metastatic risk in patients with invasive cutaneous melanoma (Press release, Castle Biosciences, JUL 9, 2020, View Source [SID1234561799]).

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The article titled, "A Systematic Review and Meta-Analysis of Gene Expression Profiling for Primary Cutaneous Melanoma Prognosis," appeared in SKIN: The Journal of Cutaneous Medicine.

The study found that of all gene expression profile tests reported for cutaneous melanoma, DecisionDx-Melanoma was the only test described in the literature or commercially available with sufficient evidence to qualify for inclusion in the study. This is the second recently published systematic review and meta-analysis that demonstrates the independence and significance of DecisionDx-Melanoma prognosis for recurrence and metastatic risk in patients with invasive cutaneous melanoma.

Lichtman et al. Study Background and Results:

The purpose of this systematic review and meta-analysis was to consolidate the rapidly evolving body of data on gene expression profiling (GEP) in melanoma prognosis.
This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)1.
The systematic review identified several GEP assays that have been described in the literature. However, aside from DecisionDx-Melanoma, none of the reported studies were supported by consistent reporting of results or enough evidence for inclusion in the meta-analysis performed by study co-authors.
The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of survival, with a significant association between Class 2 test results and recurrence-free (Hazard Ratio [HR] = 7.22; p <0.00001), distant metastasis-free (HR = 6.62; p <0.00001) and overall (HR = 7.06; p <0.00001) survival rates.
DecisionDx-Melanoma test results were also associated with sentinel lymph node biopsy status (odds ratio calculation; p<0.00001).
Results of the study indicate that the DecisionDx-Melanoma test achieved the highest Strength of Recommendation Taxonomy (SORT) level of evidence for a prognostic biomarker (Level 1 evidence). The SORT system is used by the American Academy of Dermatology (AAD) and other organizations to evaluate the quality, quantity and consistency of evidence supporting tests such as DecisionDx-Melanoma. The SORT scale evaluates both the quality of the evidence (Level 1, 2 or 3) and strength of the recommendation (A, B or C).

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2020, DecisionDx-Melanoma has been ordered more than 56,800 times for use in patients with cutaneous melanoma.

On July 9, 2020 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its second quarter 2020 financial results on Thursday, July 30, 2020 after the close of financial markets (Press release, Seattle Genetics, JUL 9, 2020, View Source [SID1234561797]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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Thursday, July 30, 2020
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 866-248-8441 (domestic) or +1 720-452-9102 (international); conference ID 1128188
Webcast with slides available at www.seattlegenetics.com in the Investors section. A webcast replay will be archived on the Company’s website.

On July 9, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on August 5, 2020, at 4:30 p.m. EDT to discuss its financial results for the fiscal third quarter ended June 30, 2020 (Press release, Arrowhead Pharmaceuticals, JUL 9, 2020, View Source [SID1234561796]).

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6856804.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6856804.

On July 9, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. Pembrolizumab is an anti-PD-1 monoclonal antibody (Press release, MacroGenics, JUL 9, 2020, View Source [SID1234561792]).

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"Current standard of care treatment for patients with metastatic gastroesophageal adenocarcinoma is heavily dependent on the use of cytotoxic chemotherapy," said Stephen Eck, M.D., Ph.D., Senior Vice President, Clinical Development & Chief Medical Officer. "The published data suggest that a chemotherapy-free regimen combining the immune-enhancing properties of margetuximab with checkpoint blockade may improve upon clinical outcomes for certain first-line patients with metastatic HER2-positive gastroesophageal adenocarcinoma and provide a strong rationale for the ongoing Phase 2/3 MAHOGANY study."

The Phase 2 study enrolled patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors were IHC3-positive or IHC2-positive/FISH-positive at diagnosis. Enrollment was regardless of PD-L1 expression status, which was subsequently determined from available archived tumor tissue.

Tolerability of margetuximab and pembrolizumab was acceptable in patients treated in this study. Grade 3 or higher treatment-related adverse events (TRAEs) were reported in 20% of patients, with anemia (4%) and infusion-related reactions (3%) being the most common. No treatment-related deaths were reported.

Patients who had received margetuximab at the recommended Phase 2 dose of 15 mg/kg every three weeks were evaluable for response. In this overall population, the objective response rate (ORR) was 18% (17/92 patients), including complete responses (CR) and partial responses (PR). The disease control rate (DCR), which includes CR, PR, and stable disease (SD), was 53% (49/92 patients). Median progression-free survival (PFS) was 2.7 months (95% CI 1.6–4.3) and median overall survival (OS) was 12.5 months (95% CI 9.1–14.1).

Activity of margetuximab and anti-PD-1 in this study was more pronounced in key biomarker-positive subgroups. The most pronounced benefit was observed in patients whose tumors had high HER2 expression at diagnosis (HER2 IHC3-positive) and were PD-L1-positive. In this double-positive subgroup, the ORR was 44% (11/25 patients) and the DCR was 72% (18/25 patients). Median PFS was 4.8 months (95% CI 1.6–13.9) and median OS was 20.5 months (95% CI 8.1–NR).

Patients with initial HER2-positive GEA may lose HER2 expression after trastuzumab-based therapy. In this second-line study, HER2 amplification was not detectable in circulating tumor DNA (ctDNA) in 42% of patients who were tested, suggesting loss of HER2 following prior trastuzumab and before treatment with margetuximab and pembrolizumab. The presence of HER2 amplification in ctDNA was associated with better response rates in this study. HER2amp-positive/HER2 IHC3-positive/PD-L1-positive ORR was 60% (9/15 patients) and DCR was 80% (12/15 patients).

Consistent with prior studies of margetuximab in other tumor types, correlative analyses of samples from GEA patients treated in the study showed an increase in anti-HER2 specific T-cell immunity, suggesting the potential for engagement of both innate and adaptive immune responses.

These data in second-line patients who were refractory to trastuzumab provide the rationale for the ongoing Phase 2/3 MAHOGANY clinical trial of margetuximab in combination with checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364). The data published in Lancet Oncology are reported as of July 10, 2019 and were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in September 2019.

About Gastric and Gastroesophageal Junction Cancer

Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

About Margetuximab

Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered using MacroGenics’ Fc Optimization technology to enhance the engagement of the immune system. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. A Phase 2/3 MAHOGANY clinical trial in of margetuximab in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364) is ongoing. Margetuximab has been granted an orphan drug designation by the FDA for the treatment of GC or GEJ cancer.

On July 9, 2020 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported certain unaudited preliminary second quarter financial results (Press release, Integra LifeSciences, JUL 9, 2020, View Source [SID1234561791]). The company also announced that it will release full second quarter 2020 financial results on Monday, August 10, 2020 at 4:30pm ET.

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Preliminary Second Quarter Revenue Results

Second quarter 2020 reported revenue is expected to be in the range of $254 million to $256 million, representing a decline of approximately 34% on a reported basis and approximately 32% on an organic basis compared to 2019. Throughout the quarter, monthly sales performance improved sequentially due to the resumption of non-emergent surgical procedures and the easing of shelter-in-place restrictions. The Company’s average daily sales in the month of June were down approximately 15% when compared to the average daily sales rate for the full second quarter of 2019. The preliminary results set forth above are unaudited and remain subject to completion of the Company’s financial closing procedures.

The Company is encouraged by the improvement in monthly sales trends during the second quarter. However, given the continued uncertainty due to the ongoing impact of COVID-19, we currently are unable to determine the impact on revenue beyond the first half of 2020, and are continuing to monitor, assess and respond to the situation. The Company will provide an update on August 10, 2020, as part of our second quarter earnings call, along with a discussion of our full second quarter financial results.

Second Quarter 2020 Financial Results Conference Call

The Company will release full second quarter 2020 financial results on Monday, August 10 after the market closes. In conjunction with the earnings release, Integra’s management team will host a conference call at 4:30 p.m. ET.

The live call is accessible by dialing (800) 263-0877 and using the passcode 4133628. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com.

A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until August 15, 2020 by dialing (888) 203-1112 and using the passcode 4133628.