On December 19, 2022 Cardinal Health (NYSE: CAH) and its board of directors reported that Aaron Alt will become the company’s new chief financial officer (CFO) (Press release, Cardinal Health, DEC 19, 2022, View Source [SID1234625395]). Alt will succeed interim CFO, Trish English and will report to CEO, Jason Hollar, as a member of the company’s Executive Committee effective Feb. 10.

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In his capacity as CFO, Alt will lead financial activities across the enterprise, including Financial Strategy, Capital Deployment, Treasury, Tax, Investor Relations, Accounting, and Reporting. Additionally, he will lead the Corporate Development team.

"We’re pleased to welcome Aaron as the new CFO of Cardinal Health," said Jason Hollar, CEO of Cardinal Health. "He’s an exceptional talent with a breadth of experience across complex organizations that will position him well for this critical companywide role. I’d also like to thank Trish for her contributions as interim CFO and her commitment to help with this transition."

Alt most recently served as EVP and CFO for Sysco Corporation, the leading global foodservice distribution company. In this role, he drove significant improvements to the balance sheet and underlying profitability of Sysco.

Prior to Sysco, Alt was SVP and CFO for Sally Beauty Holdings, an international specialty retailer and wholesale distributor of professional beauty supplies. He has also held senior executive roles in Finance, Operations and Grocery Transformation at Target Corporation. Prior to joining Target, he held senior-level Finance and Operations positions with Sara Lee Corporation.

Aaron holds an M.B.A. from the J.L. Kellogg School of Management at Northwestern University, a J.D. from Harvard Law School and a B.A. in History and Political Science from Northwestern University.

On December 19, 2022, Arcus Biosciences, Inc. (the "Company") reported positive results from the fourth interim analysis of ARC-7, its randomized, 150-patient Phase 2 trial in first-line metastatic PD-L1≥50% non-small cell lung cancer in which the Company is studying domvanalimab in combination with zimberelimab both with and without etrumadenant vs. zimberelimab monotherapy (Press release, Arcus Biosciences, DEC 19, 2022, View Source [SID1234625393]). This interim analysis was conducted at the clinical data cutoff date of August 31, 2022.

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At the time of data cutoff, efficacy was evaluated in patients who had at least 13 weeks of follow-up and were therefore potentially eligible for at least two imaging scans (n=133), and safety was evaluated in all enrolled patients (n=149). With a median follow-up time for efficacy duration of approximately 12 months, both the doublet and triplet combinations demonstrated clinically meaningful improvements in median progression-free survival (PFS) and six-month landmark PFS rates compared to zimberelimab monotherapy, with a 45% reduction in risk of disease progression or death for the doublet and 35% for the triplet.

Each of the domvanalimab-containing study arms also demonstrated clinically meaningful improvements in objective response rate (ORR) compared to zimberelimab monotherapy. Confirmed ORR was 27%, 41% and 40% for the zimberelimab monotherapy arm and the domvanalimab-doublet and -triplet arms, respectively. While the triplet arm did not show an improvement over the doublet arm, it reinforces the results observed in the doublet arm, and the study will continue to monitor PFS, as well as overall survival, for the triplet arm as these data mature.

The efficacy results including ORR and PFS are summarized in the table below:

Endpoint

zimberelimab (Z) monotherapy

(n=44)

domvanalimab + zimberelimab (DZ)

(n=44)

etrumadenant + domvanalimab +

zimberelimab (EDZ) (n=45)

Progression-free Survival (PFS)

Median in Months (95% CI)

5.4 (1.8, 9.6)

12.0 (5.5, NE)

10.9 (4.8, NE)

Hazard Ratio* (95% CI)

0.55 (0.31, 1.0)

0.65 (0.37, 1.1)

Six-month PFS rate (95% CI)

43% (27, 59)

65% (49, 80)

63% (48, 78)

Objective Response Rate (ORR)

ORR+ (95% CI)

27% (15.0, 42.8)

41% (26.3, 56.8)

40% (25.7, 55.7)

*Hazard ratio is for comparing domvanalimab-containing study arms to zimberelimab monotherapy.

+Based on confirmed response per RECIST 1.1

NE=not evaluable

No unexpected safety signals were observed across the three study arms at the time of data cutoff. The domvanalimab-containing study arms appeared to be generally well tolerated and showed an overall safety profile consistent with the known safety profiles of each individual molecule to date. Grade ≥3 treatment-emergent adverse events occurred in 58% of participants in the zimberelimab monotherapy study arm, 47% of the doublet arm, and 52% of the triplet arm. Incidence of infusion-related reactions was low across all treatment arms: 4%, 4% and 10% for zimberelimab monotherapy and the domvanalimab-doublet and -triplet arms, respectively. Immune-related adverse events, including the incidences and grades of rash and pruritus, were generally low and manageable with topical corticosteroids.

On December 19, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that it will present at the Biotech Showcase 2023 conference being held in-person on January 9-11, 2023, at the Hilton San Francisco Union Square in San Francisco, California, and virtually on January 18-19, 2023 (Press release, Anixa Biosciences, DEC 19, 2022, View Source [SID1234625392]).

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The presentation will provide an overview of Anixa’s business and highlight recent corporate achievements, including updates on its clinical programs.

Details of the presentation are as follows:

Event: Biotech Showcase 2023
Date: Monday, January 9, 2023
Time: 3:30 PM PST
Location: Yosemite-A, Hilton San Francisco Union Square

Anixa management will be available for one-on-one meetings throughout the conference.

Biotech Showcase is one of the industry’s largest annual healthcare investor and partnering conferences, bringing together biopharmaceutical and life sciences company executives, investors, sector analysts, bankers, and industry stakeholders. More than 350 presentations from mid-, small- and micro-cap public and private companies are expected to present at the event. Qualified investors and buy- and sell-side analysts are invited to request a complimentary registration to attend Biotech Showcase. For more information on attending click here.

On December 19, 2022 ADC Therapeutics SA (NYSE: ADCT) reported the appointment of Jose "Pepe" Carmona as Chief Financial Officer (CFO), effective December 19, 2022 (Press release, ADC Therapeutics, DEC 19, 2022, View Source [SID1234625391]). He will serve on the Company’s executive leadership team and succeeds Jenn Creel, who is leaving to pursue other opportunities.

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"We warmly welcome Pepe to ADC Therapeutics. As we enter the next phase of growth, I am confident that his extensive financial background, deep capital markets experience and proven leadership in the pharmaceutical industry will help drive our corporate objectives and deliver long-term value for shareholders," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We would like to sincerely thank Jenn Creel for her many contributions to the Company, including building and leading the financial organization through multiple stages of our evolution."

Mr. Carmona is a seasoned CFO with over 20 years of leadership, commercial and partnership experience in the pharmaceutical industry, both in the U.S. and internationally. He most recently served as CFO of Rubius Therapeutics where he was responsible for all financial functions as well as business development, investor relations, information technology and procurement. Mr. Carmona helped capitalize the company through both dilutive and non-dilutive financing vehicles and brought the organization from a research-stage company to a clinical-stage company. Prior to joining Rubius, Mr. Carmona was the CFO of Radius Health and Innocoll. During his 12 years at Novartis, Mr. Carmona held financial management positions with increasing responsibilities in various divisions and geographies, including CFO Alcon for Europe, Middle East and Africa. He currently serves on the board of directors of HotSpot Therapeutics and Senda Biosciences.

"I am thrilled to join ADC Therapeutics, especially at this exciting point in the Company’s evolution," said Mr. Carmona. "I believe the Company possesses great potential with its industry-leading expertise and a robust pipeline of innovative assets. I welcome the opportunity to collaborate with my new colleagues and contribute to our mission of delivering transformative treatment options to people with cancer."

On December 19, 2022 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy (Press release, AstraZeneca, DEC 19, 2022, View Source [SID1234625381]).

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Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DESTINY-Breast04 Phase III trial, which were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting and simultaneously published in The New England Journal of Medicine.1

In the trial, Enhertu reduced the risk of disease progression or death by 50% versus physician’s choice of chemotherapy (based on a hazard ratio [HR] of 0.50; 95% confidence interval [CI]: 0.40-0.63; p<0.001) in patients with HER2-low metastatic breast cancer with HR-positive or HR-negative disease. A median progression-free survival (PFS) of 9.9 months was seen with Enhertu versus 5.1 months in those treated with chemotherapy, as assessed by blinded independent central review (BICR). A 36% reduction in the risk of death (HR 0.64; 95% CI: 0.49-0.84; p=0.001) was seen with Enhertu compared to chemotherapy with a median overall survival (OS) of 23.4 months versus 16.8 months.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "Enhertu is the first-ever HER2-directed medicine to show a survival benefit in patients with HER2-low metastatic breast cancer, confirming the importance of targeting lower levels of HER2 expression in patients previously classified as HER2-negative. The CHMP’s recommendation is encouraging and supports our ambition to evolve the way breast cancer is classified and treated to ultimately improve patient outcomes."

Ken Takeshita, Global Head, R&D Daiichi Sankyo, said: "This positive CHMP opinion recognises the unmet need in the European Union for patients with HER2-low metastatic breast cancer. Currently, once patients with HR-positive disease progress on hormone therapy there are limited effective treatments, and few targeted options are available for patients with HR-negative disease. We look forward to the European Commission decision and aim to bring Enhertu to eligible patients as soon as possible."

The safety profile observed in patients treated with Enhertu in the DESTINY-Breast04 trial was consistent with that seen in other trials of Enhertu in breast cancer with no new safety signals identified.

Notes

Breast cancer and HER2 expression
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.2 More than two million patients with breast cancer were diagnosed in 2020 with nearly 685,000 deaths globally.2 In Europe, approximately 531,000 breast cancer patients are diagnosed annually with nearly 141,000 deaths.3

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumours.4

HER2 expression is currently determined by an immunohistochemistry (IHC) test which estimates the amount of HER2 protein on a cancer cell, and/or an in situ hybridisation (ISH) test, which counts the copies of the HER2 gene in cancer cells.4,5 HER2 tests provide IHC and ISH scores across the full HER2 spectrum and are routinely used to determine appropriate treatment options for patients with metastatic breast cancer.

HER2-positive cancers are currently defined as HER2 expression measured as IHC 3+ or IHC 2+/ISH+, and HER2-negative cancers are defined as HER2 expression measured as IHC 0, IHC 1+ or IHC 2+/ISH-.4 However, approximately half of all breast cancers are HER2-low, defined as a HER2 score of IHC1+ or IHC 2+/ISH-.6-8 HER2-low occurs in both HR-positive and HR-negative disease.9

Currently, patients with HR-positive metastatic breast cancer and HER2-low disease have limited effective treatment options following progression on endocrine (hormone) therapy.10 Additionally, few targeted options are available for those with HR-negative disease.11

DESTINY-Breast04
DESTINY-Breast04 is a global, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive or HR-negative, HER2-low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomised 2:1 to receive either Enhertu or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on BICR. Key secondary endpoints include PFS based on BICR in all randomised patients (HR-positive and HR-negative disease), OS in patients with HR-positive disease and OS in all randomised patients (HR-positive and HR-negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety.

DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, based on the results from the DESTINY-Breast03 trial. Enhertu also is approved in several countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (5.4mg/kg) is approved in Brazil and the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, based on the results of the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 and/or the DESTINY-Gastric02 trial.

Enhertu development programme
A comprehensive global development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu in breast, non-small cell lung and gastric cancer are currently under review in several countries.