On May 4, 2022 Novartis reported updated median overall survival (OS) results for Kisqali (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (Press release, Novartis, MAY 4, 2022, View Source [SID1234613545]). The analysis of patients treated in first-line with Kisqali plus fulvestrant demonstrated a significant OS benefit of nearly 16 months compared to those treated with fulvestrant alone. This updated exploratory OS analysis from the Phase III MONALEESA-3 study will be presented as a late-breaker mini-oral presentation at the 2022 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress (Abstract #LBA4).

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"MONALEESA-3 results continue to demonstrate the survival benefit of treatment with ribociclib for postmenopausal women with advanced breast cancer," said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center. "Whether partnered with fulvestrant or an aromatase inhibitor in the first-line setting, ribociclib offers oncologists a CDK4/6 inhibitor with consistent benefit in providing women with HR+/HER2- advanced breast cancer more quality time, regardless of their disease characteristics."

In this MONALEESA-3 exploratory analysis, patients were further evaluated for a median of 71 months, more than two-and-a-half years of additional follow-up since the final key secondary endpoint OS analysis, which was presented at ESMO (Free ESMO Whitepaper) Congress 2019 and published in the New England Journal of Medicine. The final OS analysis demonstrated a statistically significant OS benefit for Kisqali in combination with fulvestrant and a relative reduction in the risk of death by 28% compared to fulvestrant alone in the full population (HR=0.72; 95% CI: 0.568-0.924; p=0.00455)1,5-6.

This new updated analysis with a median follow-up of five years found that in the first-line setting, Kisqali plus fulvestrant (n=237) achieved 67.6 months median OS as compared to 51.8 months for those treated with fulvestrant alone (n=128) (HR=0.673; 95% CI: 0.504-0.899)1. Patients treated with Kisqali plus fulvestrant compared to those on fulvestrant alone in the first-line setting experienced over one-and-a-half years of additional delay to subsequent use of chemotherapy (49.2 months versus 29.0 months, respectively; HR=0.624; 95% CI: 0.481-0.810)1.

With this extended follow-up, the estimated survival rate at five years was 56.5% (95% CI: 49.5-62.9) for women who received Kisqali in combination with fulvestrant in first-line compared to 42.1% (95% CI: 33.2-50.7) for women who received fulvestrant alone1. Additionally, 16.5% of patients in the Kisqali plus fulvestrant arm (n=39) compared to 8.6% of those in the fulvestrant only arm (n=11) were still ongoing on therapy at this longer follow-up1. No new adverse events were observed.

"It is a tremendous achievement to see such remarkable, consistent overall survival results from the MONALEESA clinical trial program, demonstrating how Novartis is transforming care for people with breast cancer as we continue to work toward cures," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "The unique profile of Kisqali continues to be reinforced, with results from MONALEESA-3 pushing the boundaries of how using a Kisqali-combination treatment regimen can extend lives of postmenopausal women living with HR+/HER2- advanced breast cancer without compromising quality of life."

The MONALEESA-3 overall survival data from ESMO (Free ESMO Whitepaper) Congress 2019 are featured in a media release6.

About Kisqali (ribociclib)
Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all three Phase III advanced trials1-10, and is recognized by the National Comprehensive Cancer Network (NCCN) guidelines as the only CDK4/6 inhibitor with overall survival benefit in first-line HR+/HER2- advanced breast cancer11. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line premenopausal patients with HR+/HER2- advanced breast cancer12. Further, Kisqali in combination with either letrozole or fulvestrant has received a score of four out of five for first-line postmenopausal patients with HR+/HER2- advanced breast cancer13.

Kisqali has been approved in more than 95 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission, for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination either with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy14-15. Kisqali in combination with fulvestrant is approved as initial endocrine-based therapy or following disease progression on endocrine therapy in men by the FDA14.

Novartis is continuing to reimagine cancer with additional trials of Kisqali. NATALEE is a large confirmatory clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)16. Novartis is collaborating with SOLTI, who is leading HARMONIA to test the hypothesis whether Kisqali changes tumor biology to enable a better response to endocrine-based therapy compared to Ibrance* for patients with advanced HR+/HER2-, HER2-enriched subtype.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.

On May 4, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported an update on the first quarter of 2022 and confirms its financial guidance for the full year (Press release, MediGene, MAY 4, 2022, View Source [SID1234613544]). The full version of the Quarterly Statement Q1 2022 can be downloaded here: View Source

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Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Medigene continues to develop technology to power the activity and safety of T cell receptor-modified T cell (TCR-T) immunotherapies in solid cancers. Our extensive partnership signed with BioNTech SE (BioNTech) in February not only validated our leading position in the field but also provided a sound financial basis at an important phase in the Company’s evolution. Also in February, we reported that our blood cancer program MDG1011 was successfully produced, safe, well tolerated, with signals of both biological and/or clinical activity.

The Company is strategically positioned to increase value through partnerships and internal discovery, seeking novel T cell receptors (TCRs) and developing the necessary vital tools that will make TCR-T therapies safer, more efficacious and cost effective."

Business review since beginning of 2022 and outlook

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s PRAME-specific TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies safer and more effictive.

Under the agreement, Medigene received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity. One patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Tools to empower TCR-T therapies

Medigene develops several tools to make TCR-T therapies even safer, more specific and more effective, especially for use in solid cancers. In March 2022, preclinical data on Medigene’s PD1-41BB switch receptor were published in the peer-reviewed scientific publication "T-Cells Expressing a Highly Potent PRAME-Specific T-Cell Receptor in Combination with a Chimeric PD1-41BB Co-Stimulatory Receptor Show a Favorable Preclinical Safety Profile and Strong Anti-Tumor Reactivity" in the scientific journal Cancers.

Development partnerships

Medigene continues its successful collaboration with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and has initiated operations under the new partnership with BioNTech. Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, has reported that its development activities would be delayed due to the COVID-19 pandemic, and separately has temporarily suspended Medigene’s activities within the second TCR-T development project since April 2022.

To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Financial development and financial forecast

As of 31 March 2022, cash and cash equivalents amounted to EUR47.8 m (31 December 2021: EUR22.4 m). In Q1 2022, Medigene generated revenues of EUR23.0 m (Q1 2021: EUR2.1 m) and had research and development expenses of EUR2.0 (Q1 2021: EUR4.0 m). As a result, the earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to EUR16.8 m (Q1 2021: EUR‑3.1 m).

Currently, Medigene does not expect any material impact on revenues, research and development expenses and EBITDA due to COVID-19 or the Ukraine crisis. Thus, Medigene confirms its financial forecast for 2022 published in the Group Management’s Discussion and Analysis 2021 and continues to expect revenues of EUR23 – 28 m, research and development expenses of EUR11 – 15 m and a positive EBITDA in the amount of EUR3 – 5 m in 2022. Based on its current planning, the Company has sufficient financial resources to fund business operations into Q4 2024.

Conference Call

Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2022, but we remain available in the usual way for all enquiries.

On May 4, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that members of management will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Wednesday, May 11, 2022 at 10:40 a.m. P.T. in Las Vegas, NV (Press release, argenx, MAY 4, 2022, View Source [SID1234613543]). A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 90 days following the presentation.

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On May 4, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the quarter March 31, 2022 on Monday, May 9, 2022, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, MAY 4, 2022, View Source [SID1234613541]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, May 10, 2022, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; and Sue Smith, Chief Commercial Officer.

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On May 4, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new consensus data from a survey of leading breast cancer oncologists in Europe suggest the importance of gene expression profile (GEP) testing in guiding treatment decisions for women with early-stage breast cancer (Press release, Veracyte, MAY 4, 2022, View Source [SID1234613540]). The findings, from the PROCURE study, were presented today at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2022, taking place May 3-5 in Berlin, Germany .

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The PROCURE study utilized Delphi methodology to generate consensus regarding the clinical utility of GEP tests, including Veracyte’s Prosigna Breast Cancer Assay, in breast cancer treatment. A scientific committee of eight breast cancer experts developed a questionnaire, which was used to survey 133 specialists from 11 European countries. Consensus was achieved when at least 70 percent of respondents agreed on a topic. Among the findings:

88 percent of participants give importance to GEP prognostic results when deciding on chemotherapy usage in the adjuvant setting for early-stage breast cancer patients whose disease has not spread to the lymph nodes;
75 percent also consider it important when deciding on chemotherapy in the adjuvant setting in early-stage patients with 1 to 3 positive lymph nodes;
76 percent of participants agreed on the clinical utility of molecular subtype information from GEP testing to assess likelihood of disease recurrence among early-stage breast cancer patients who are hormone-receptor positive; and
75 percent think the use of molecular subtype information is useful to identify such patients who may safely avoid chemotherapy.
"Our findings show that use of gene expression profile tests has become standard of care among physicians in Europe to help guide treatment decisions for women with early-stage breast cancer," said Giuseppe Curigliano, M.D., Ph.D., professor of medical oncology at the University of Milano and the head of the Division of Early Drug Development at the European Institute of Oncology, IRCCS, who presented the study findings. "We also found that physicians agree on the value of molecular subtype information, a more recent advance in such tests, to help inform treatment for individual patients."

Also among the findings, 67 percent of respondents believe that GEP tests can help physicians determine the most appropriate type of chemotherapy treatment.

"While a large-scale, prospective trial to determine such predictive information from GEP testing would be valuable, our findings suggest more education is needed among breast cancer specialists regarding the role that GEP tests play today," said Dr. Curigliano.

"We believe the PROCURE study will provide much-needed clarity to breast cancer clinicians and their patients about the clinical utility of GEP testing," Kelly Marcom, M.D., Veracyte’s medical director for breast cancer. "We’re grateful for the opportunity to sponsor this important study and to demonstrate our commitment to the global breast cancer community."