Ultime notizie per Astellas Pharma (OTC:ALPMY) Azioni

ASTELLAS PHARMA INC

Astellas Pharma Inc is a specialty global pharmaceutical company. The company focuses on accelerating the discovery, development and commercialization of ground-breaking innovations that could redefine expectations of care for difficult-to-treat diseases. The group is committed to driving innovation in immuno-oncology, gene therapy, mitochondria, blindness and regeneration, and targeted protein degradation. The company operates its business in approximately 70 countries around the world. Its core products include anticancer agents like XTANDI, XOSPATA, and PADCEV; VEOZAH for the treatment of vasomotor symptoms due to menopause; Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder (OAB); and Prograf, an immunosuppressant for organ transplantation.

ASTELLAS PHARMA UNSP/ADR by Astellas Pharma, Inc.

Astellas Pharma Inc

William Blair has initiated coverage on Apellis Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLS#NASDAQ">APLS</a>) and notes that Apellis was the first company to successfully target complement C3, which has led to the approval of two therapies: Empaveli (systemic pegcetacoplan) for paroxysmal nocturnal hemoglobinuria and Syfovre (intravitreal pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration.
William Blair writes that although Empaveli has established a solid position in the PNH market, short-term challenges are anticipated due to the emergence of a new competitor, Novartis AG&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Fabhalta (iptacopan).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40261396/apellis-pharmaceuticals-pegcetacoplan-meets-primary-goal-in-late-stage-study-in-patients-with-rar" rel="noreferrer noopener">Apellis Pharmaceuticals&#8217; Pegcetacoplan Meets Primary Goal In Late-Stage Study In Patients With Rare Kidney Diseases</a>.
However, Empaveli has a more significant market opportunity in C3 glomerulopathy (C3G) and immune-complex membranoproliferative glomerulonephritis (IC-MPGN), especially following the strong top-line results from the Phase 3 VALIANT study.
William Blair projects that it could receive approval by late 2025, with peak sales estimates for C3G and IC-MPGN reaching $700 million by 2031.
The analyst has initiated the coverage with an Outperform rating and estimates a fair value for <a target="_blank" href="https://www.benzinga.com/quote/APLS/analyst-ratings" rel="noreferrer noopener">shares of $50</a>.
Syfovre received approval in February 2023, while Astellas Pharma Inc&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMF#OTC">ALPMF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMY#OTC">ALPMY</a>) drug was approved in August 2023. According to the analyst, Syfovre presents a more attractive efficacy profile and a more advantageous label, permitting monthly or bi-monthly dosing and treatment beyond 12 months (although the label for Izervay may be updated to include these options in November). 
Nevertheless, the analyst notes that the market is sufficiently large to accommodate multiple blockbuster drugs.
Thus, even though Syfovre has a competitive advantage over Izervay, William Blair believes both medications can thrive in light of the extensive market, significant unmet needs, and the absence of alternative treatments.
With an assumption of only 30% peak market penetration among patients treated by injecting physicians and a consistent rise in referral rates without an increase in diagnosis rates, the analyst projects U.S. peak sales for Syfovre to reach $2.0 billion by 2030.
Price Action: APLS stock is down 0.95% at $27.68 at last check Wednesday.
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ALPMF

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APLS

Syfovre's Competitive Edge Highlights Bright Future For Apellis Pharmaceuticals, Analyst Initiates With Bullish Pitch

Reported Earlier, Takeda, Astellas, And SMBC Partner To Establish Ciconia Bioventures, Driving Early-Stage Drug Discovery In Japan

- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -

Astellas Announces FDA Listing Of DIGITIVA, A Non-Invasive Digital Health Solution For Heart Failure Management

<ul>
<li>First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1</li>
<li>European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1</li>
</ul>

Reported Earlier, Astellas' PADCEV In Combination With KEYTRUDA Approved By European Commission, For First-Line Treatment Of Advanced Urothelial Cancer

HIGHLIGHT 1&trade; study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy&nbsp;-

Astellas Starts Phase 3 Trial Of Fezolinetant Targeting VMS In Women Undergoing Adjuvant Endocrine Therapy For Breast Cancer

In its second-quarter earnings release, Nuvation Bio Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NUVB#NYSE">NUVB</a>) announced that it has decided to halt work on NUV-868, its BD2-selective BET inhibitor, while <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/b40157849/nuvation-bio-reports-second-quarter-2024-financial-results-and-provides-business-update" rel="noreferrer noopener">considering the program&#8217;s future</a>.
The company said it concluded the Phase 1b dose escalation study of NUV-868 in combination with AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>)-Merck &amp; Co Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Lynparza (olaparib) for ovarian, pancreatic, metastatic castration-resistant prostate (mCRPC), triple-negative breast cancer, and other solid tumors, and with Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)-Astellas Pharma Inc&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMF#OTC">ALPMF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ALPMY#OTC">ALPMY</a>) Xtandi (enzalutamide) for mCRPC.
The company completed an internal analysis of efficacy and safety data from Phase 1 monotherapy and Phase 1b combination studies of NUV-868.
Following this analysis, Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or combined with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs.
The company is evaluating the next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve patient outcomes.
&#8220;As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a Phase 2 study of NUV-868 in the solid tumor indications studied to date. This decision comes after a careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. We are exploring next steps for NUV-868 in new indications and will share updates as available,&#8221; said David Hung, Founder, President, and CEO of Nuvation Bio.
Two years back, Nuvation Bio discontinued the clinical development of NUV-422 after an internal risk-benefit analysis factoring in feedback from the FDA in a partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its <a target="_blank" href="https://www.benzinga.com/general/biotech/22/08/28290264/after-fda-hold-nuvation-bio-stops-nuv-422-cancer-development-program" rel="noreferrer noopener">combination Phase 1b/2 studies</a>.
As of June 30, 2024, Nuvation Bio had cash, cash equivalents, and marketable securities of $577.2 million.
Price Action: NUVB stock is down 7.41% at $3.11 at last check Monday.
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Don&#8217;t miss the opportunity to dominate in a volatile market at the <a target="_blank" href="https://www.benzinga.com/events/small-cap/global-small-cap-conference-2024/" rel="noreferrer noopener">Benzinga SmallCAP Conference</a> on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you&#8217;re a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!

Earnings

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NUVB

Small-Cap Cancer-Focused Nuvation Bio Pulls Plug On Early-Stage Program After Considering Phase 1 Solid Tumor Data

-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union&nbsp;
-&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; A decision on the EU marketing authorization is expected by October 2024
TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503,&nbsp;President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.1 If approved, zolbetuximab would become the first and only CLDN18.2-targeted therapy available for patients in the European Union.

Global

Astellas Receives Positive CHMP Opinion For Zolbetuximab In Combination With Chemotherapy For Treatment Of Advanced Gastric And Gastroesophageal Junction Cancer

- If approved, enfortumab vedotin&nbsp;in combination with pembrolizumab&nbsp;will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer
- Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin&nbsp;in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1 &nbsp;
TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503,&nbsp;President and CEO: Naoki Okamura, "Astellas") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEV&#x2122;&nbsp;(enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA&#xAE; (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable&nbsp;or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.2

Astellas Receives Positive CHMP Opinion For PADCEV In Combination With KEYTRUDA For First-Line Treatment Of Advanced Bladder Cancer

Astellas Collaborates With YASKAWA To Create An Innovative Cell Therapy Ecosystem Through The Integration Of Pharmaceutical And Robotics Technologies

- Leverages Poseida&#39;s proprietary allogeneic CAR-T platform to develop innovative convertibleCAR&reg;&nbsp;programs targeting solid tumors -

PSTX

Reported Earlier, Astellas And Poseida Therapeutics Enter Into Research Collaboration And License Agreement To Develop Novel Allogeneic Cell Therapies In Oncology

<ul>
<li>TANDI is now the first and only novel hormone therapy available for the treatment of high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the European Union (EU)</li>
<li>XTANDI can be given alone or in combination with androgen deprivation therapy</li>
<li>Approval is based on results from the positive Phase 3 EMBARK study which showed XTANDI alone or in combination with leuprolide reduced the risk of metastasis or death</li>
</ul>

Reported Earlier, Astellas' XTANDI (Enzalutamide) Granted European Commission Approval For Use In Additional Recurrent Early Prostate Cancer Treatment Setting

In&nbsp;Japan, two Phase 3 clinical studies are underway. STARLIGHT 2 is evaluating the efficacy and safety of fezolinetant once-daily through 12 weeks. STARLIGHT 3 is evaluating the safety and tolerability of fezolinetant once-daily through 52 weeks.

Reported Earlier, Astellas Initiated Phase 3 Clinical Studies Of Fezolinetant For VMS Associated With Menopause In Japan

&ndash; Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy &ndash;&nbsp;
&ndash; If approved, PADCEV with KEYTRUDA would be the first combination in&nbsp;Japan&nbsp;to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer &ndash;&nbsp;

Astellas Submits Supplemental New Drug Application In Japan For PADCEV™ With KEYTRUDA® For First-Line Treatment Of Advanced Bladder Cancer

According to the Global Data report, the pharma sector in Q3 2023 witnessed deals worth $28 billion, down 28% from the $54 billion recorded in Q2 2023.&nbsp;
Deal volume fell 9% from 242 deals in Q2 2023 to 221 M&amp;A deals in&nbsp;<a class="editor-rtfLink" href="https://www.globaldata.com/store/report/healthcare-industry-m-and-a-deals-by-theme-quarterly-analysis/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Q3</a>&nbsp;2023.
PricewaterhouseCoopers&nbsp;<a class="editor-rtfLink" href="https://www.pwc.com/us/en/industries/health-industries/library/pharma-life-sciences-deals-outlook.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">wrote</a>&nbsp;in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. &quot;As regulators&#39; perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.&quot;
&quot;Despite some stabilization in the macroeconomic environment and the potential for a soft landing in sight, continued geopolitical and regulatory uncertainty seems a given in 2024,&quot; PWC added in its report.
The pharmaceutical and life sciences sector experienced a notably robust year in 2023, nearing pre-pandemic levels in both M&amp;A deal value and volume, the PWC report added.&nbsp;
Anticipations for 2024 suggest continuing this trend, projecting comparable activity levels within the range of $225 billion to $275 billion across all subsectors.
Notable Deals in 2023
<ul>
<li>Pfizer Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) acquired&nbsp;Seagen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sgen#NASDAQ">SGEN</a>)<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/12/36198526/pfizer-clears-required-regulatory-hurdles-to-complete-43b-seagen-acquisition" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">&nbsp;for $43 billion.</a></li>
<li>Bristol Myers Squibb &amp; Co&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/bmy#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">BMY</a>) agreed to acquire&nbsp;Karuna Therapeutics Inc&nbsp;KRTX for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/12/36360205/bristol-myers-squibb-scoops-up-schizophrenia-player-karuna-therapeutics-in-massive-14b-deal" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">estimated cash acquired</a>.&nbsp;</li>
<li>Merck &amp; Co&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) acquired&nbsp;Prometheus Biosciences&nbsp;for $200.00 per share in cash for a total equity&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/08/33491400/merck-swings-into-q2-loss-on-prometheus-biosciences-acquisition-charge-but-raises-fy23-revenue-ou" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">value of ~$10.8 billion</a>.</li>
<li>AbbVie Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abbv#NYSE">ABBV</a>) to acquire&nbsp;ImmunoGen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imgn#NASDAQ">IMGN</a>) and its flagship cancer therapy Elahere, for $31.26 per share in cash. The transaction values ImmunoGen at a total equity value of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/11/36020779/immunogens-flagship-cancer-therapy-draws-abbvies-attention-with-10-1b-deal" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">approximately $10.1 billion</a>.&nbsp;</li>
<li>AbbVie Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abbv#NYSE">ABBV</a>) will acquire psychiatric and neurological disorders player&nbsp;Cerevel Therapeutics Holdings, Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/cere#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">CERE</a>) for $45 per share in cash with a total equity value of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/12/36138161/why-cerevel-therapeutics-stock-is-higher" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">approximately $8.7 billion</a>.</li>
<li>Biogen Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/biib#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">BIIB</a>) agreed to acquire&nbsp;Reata Pharmaceuticals Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/reta#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">RETA</a>) for $172.50 per share in cash, reflecting an enterprise value of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/07/33440534/biogen-bolsters-rare-disease-portfolio-agrees-to-buy-reata-pharmaceuticals-with-enterprise-value-" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">approximately $7.3 billion</a>.</li>
<li>Bristol Myers Squibb &amp; Co&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/bmy#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">BMY</a>) agreed to purchase&nbsp;Mirati&nbsp;Therapeutics Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mrtx#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MRTX</a>) at $58.00 per share in cash, amounting to an overall equity valuation of $4.8 billion, with an additional Contingent Value Right at $12.00 per share in cash, offering an extra&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/10/35141493/bristol-myers-squibb-strengthens-oncology-portfolio-with-mirati-therapeutics-5b-deal" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">$1.0 billion in value opportunity</a>.</li>
<li>Japanese healthcare company&nbsp;Astellas Pharma Inc&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/alpmy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ALPMY</a>) has agreed to buy&nbsp;Iveric Bio Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/isee#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ISEE</a>) for $40.00 per share in cash for a total equity value of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/05/32112605/astellas-pharma-acquires-iveric-bio-for-5-9b-to-focus-on-blindness-regeneration" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">approximately $5.9 billion</a>.</li>
<li>Most recently,&nbsp;Bristol Myers Squibb &amp; Co&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/bmy#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">BMY</a>) has agreed to acquire&nbsp;RayzeBio Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ryzb#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">RYZB</a>) for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/12/b36382478/bristol-myers-squibb-adds-premier-radiopharmaceutical-platform-with-acquisition-of-rayzebio" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">estimated cash acquired</a>.</li>
<li>Image by Steve Buissinne from Pixabay</li>
</ul>

ABBV

BIIB

BMED

CERE

FHLC

Harvard Apparatus Regenerative Technology

HART

HTEC

IMGN

ISEE

iShares Trust S&P Global Healthcare Sector Index Fund

iShares Trust Dow Jones US Healthcare Sector Index Fund

MDEV

MRTX

PINK

RETA

RYZB

SGEN

Upward Trajectory For Biotech/Pharma M&A: Sector Trends Towards Pre-Pandemic Levels, Forecasts Positive For 2024

Elpiscience And Astellas Announce Research Collaboration And License Agreement For Novel Bispecific Macrophage Engager

European Medicines Agency Recommends Astellas' Arpraziquantel For Treatment Of Schistosomiasis In Preschool-Aged Children

Approval is based on results from the Phase 3 KEYNOTE-A39 trial, which demonstrated a superior overall survival benefit with KEYTRUDA plus Padcev versus platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin) in these patients
Approval expands the use of KEYTRUDA plus Padcev for locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility
Merck (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck&#39;s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial cancer. The FDA approved this application nearly five months ahead of the PDUFA goal date of May 9, 2024.
The approval is based on data from the Phase 3 KEYNOTE-A39 trial (also known as EV-302) in 886 patients with locally advanced or metastatic urothelial cancer, which was conducted in a research collaboration with Pfizer (previously Seagen) and Astellas. In the trial, KEYTRUDA plus enfortumab vedotin demonstrated a statistically significant improvement in the trial&#39;s major efficacy endpoints of overall survival (OS) and progression-free survival (PFS) versus platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin). KEYTRUDA plus enfortumab vedotin reduced the risk of death by&nbsp;53%&nbsp;(HR=0.47 [95%&nbsp;CI, 0.38-0.58]; p&lt;0.0001) versus platinum-based chemotherapy. Median OS was 31.5 months (95%&nbsp;CI, 25.4-not reached) for KEYTRUDA plus enfortumab vedotin versus 16.1 months (95%&nbsp;CI, 13.9-18.3) for platinum-based chemotherapy. KEYTRUDA plus enfortumab vedotin reduced the risk of disease progression or death by&nbsp;55%&nbsp;(HR=0.45 [95%&nbsp;CI, 0.38-0.54]; p&lt;0.0001) versus platinum-based chemotherapy. Median PFS was 12.5 months (95%&nbsp;CI, 10.4-16.6) for KEYTRUDA plus enfortumab vedotin versus 6.3 months (95%&nbsp;CI, 6.2-6.5) for platinum-based chemotherapy.
The trial also demonstrated a statistically significant improvement in objective response rate (ORR) in patients randomized to receive KEYTRUDA plus enfortumab vedotin compared with patients randomized to receive platinum-based chemotherapy. The ORR was&nbsp;68%&nbsp;(95%&nbsp;CI, 63-72) for KEYTRUDA plus enfortumab vedotin versus&nbsp;44%&nbsp;(95%&nbsp;CI, 40-49) for platinum-based chemotherapy (p&lt;0.0001). For KEYTRUDA plus enfortumab vedotin, the complete response (CR) rate was&nbsp;29%&nbsp;and the partial response (PR) rate was&nbsp;39%, and for platinum-based chemotherapy, the CR rate was&nbsp;12%&nbsp;and the PR rate was&nbsp;32%. Efficacy results (OS, PFS and ORR) were consistent across all stratified patient subgroups.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see &quot;Selected Important Safety Information&quot; below.
&quot;Advanced bladder cancer is a common cause of cancer-related death,&quot; said Dr. Thomas Powles, primary investigator of KEYNOTE-A39, professor of Genitourinary Oncology and director, Barts Cancer Center. &quot;The overall survival benefit seen in the KEYNOTE-A39 trial demonstrates the potential for KEYTRUDA in combination with enfortumab vedotin to impact the first-line treatment of patients with locally advanced or metastatic urothelial cancer. In my opinion, this is a meaningful advancement over platinum-based chemotherapy in the systemic treatment of these patients.&quot;
&quot;The landmark findings from the KEYNOTE-A39 trial are the first positive Phase 3 results combining a PD-1 inhibitor and an antibody-drug conjugate as first-line treatment for patients with locally advanced or metastatic urothelial cancer. This combination has the potential to change the treatment paradigm in advanced urothelial cancer and to help these patients live longer,&quot; said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. &quot;Today&#39;s approval reinforces the value of advancing novel combinations with KEYTRUDA to provide these patients with a treatment option.&quot;
Results from KEYNOTE-A39&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.merck.com%2Fnews%2Fkeytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-death-by-more-than-half-versus-chemotherapy-in-patients-with-previously-untreated-locally-advanced-or-metasta%2F&amp;esheet=53871946&amp;newsitemid=20231215248830&amp;lan=en-US&amp;anchor=were+presented&amp;index=1&amp;md5=a1c7e80ecaaf9c6a8e9d2882c184a059">were presented</a>&nbsp;at the European Society for Medical Oncology Congress 2023 as late-breaking data during a Presidential Symposium session. KEYTRUDA plus enfortumab vedotin was previously approved under the FDA&#39;s accelerated approval program for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are not eligible to receive cisplatin-containing chemotherapy based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Pfizer and Astellas. In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit; these accelerated approval requirements have been fulfilled with the data from KEYNOTE-A39.
This approval was reviewed under the FDA&#39;s Real-Time Oncology Review program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible.
Study design and additional data supporting the approval
KEYNOTE-A39 is an open-label, multicenter, randomized, active-controlled Phase 3 trial (ClinicalTrials.gov,&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04223856&amp;esheet=53871946&amp;newsitemid=20231215248830&amp;lan=en-US&amp;anchor=NCT04223856&amp;index=2&amp;md5=b6400413f5f37bb790171088fd23f4a8">NCT04223856</a>) evaluating KEYTRUDA plus enfortumab vedotin compared to platinum-based chemotherapy (gemcitabine plus cisplatin or carboplatin) for the treatment of patients with locally advanced or metastatic urothelial cancer who received no prior systemic therapy for locally advanced or metastatic disease. Patients randomized to the chemotherapy arm were allowed to receive maintenance immunotherapy. The trial enrolled 886 patients who were randomized (1:1) to receive either:
<ul>
<li>KEYTRUDA 200 mg over 30 minutes on Day 1 and enfortumab vedotin 1.25 mg/kg on Days 1 and 8 of each 21-day cycle. KEYTRUDA was given approximately 30 minutes after enfortumab vedotin. Treatment was continued until disease progression or unacceptable toxicity. In the absence of disease progression or unacceptable toxicity, KEYTRUDA was continued for up to two years, or;</li>
<li>Gemcitabine 1000 mg/m2&nbsp;on Days 1 and 8 of a 21-day cycle with cisplatin 70 mg/m2&nbsp;or carboplatin (AUC 4.5 or 5) on Day 1 of a 21-day cycle. Treatment was continued until disease progression or unacceptable toxicity for up to 6 cycles.</li>
</ul>
Randomization was stratified by cisplatin eligibility, PD-L1 expression and presence of liver metastases.
The major efficacy outcome measures were OS and PFS as assessed by blinded independent central review (BICR) according to RECIST v1.1. Additional outcome measures included ORR as assessed by BICR.
Among patients who received KEYTRUDA and enfortumab vedotin (n=440), the median duration of exposure to KEYTRUDA was 8.5 months (range: 9 days to 28.5 months). Fatal adverse reactions occurred in&nbsp;3.9%&nbsp;of patients receiving KEYTRUDA plus enfortumab vedotin, including acute respiratory failure (0.7%), pneumonia (0.5%) and pneumonitis/interstitial lung disease (ILD) (0.2%). Serious adverse reactions occurred in&nbsp;50%&nbsp;of patients receiving KEYTRUDA in combination with enfortumab vedotin; the serious adverse reactions in &ge;2%&nbsp;of patients were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%) and hyperglycemia (2%). Permanent discontinuation of KEYTRUDA occurred in&nbsp;27%&nbsp;of patients. The most common adverse reactions (&ge;2%) resulting in permanent discontinuation of KEYTRUDA were pneumonitis/ILD (4.8%) and rash (3.4%). The most common adverse reactions (&ge;20%) occurring in patients treated with KEYTRUDA in combination with enfortumab vedotin were rash (68%), peripheral neuropathy (67%), fatigue (51%), pruritus (41%), diarrhea (38%), alopecia (35%), weight loss (33%), decreased appetite (33%), nausea (26%), constipation (26%), dry eye (24%), dysgeusia (21%) and urinary tract infection (21%).

FDA Approves Expanded Indication For KEYTRUDA Plus Padcev For The First-Line Treatment Of Adult Patients With Locally Advanced Or Metastatic Urothelial Cancer

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Seagen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGEN#NASDAQ">SGEN</a>) and Astellas Pharma Inc. (TSE:4503 &ldquo;Astellas&rdquo;) today announced results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV&reg; (enfortumab vedotin-ejfv) in combination with KEYTRUDA&reg; (pembrolizumab) versus chemotherapy. The combination improved overall survival (OS) and progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023 as part of the Presidential Session (Abstract #LBA6).
Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV&reg; (enfortumab vedotin-ejfv) and KEYTRUDA&reg; (pembrolizumab) in First-Line Advanced Bladder Cancer
&ndash; Risk of death was reduced by 53% in patients treated with enfortumab vedotin plus pembrolizumab compared to chemotherapy &ndash;
&ndash; Enfortumab vedotin plus pembrolizumab improved median overall survival by more than 15 months vs. chemotherapy &ndash;
&ndash; Results will form the basis of global regulatory submissions &ndash;

Seagen And Astellas Announced Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival In Patients Treated with PADCEV And KEYTRUDA In First-Line Advanced Bladder Cancer

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Press Releases

Astellas to Present VEOZAH™ (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society

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Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure

Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

Japan's Ministry of Health, Labour and Welfare Approves PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma

Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications

Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause

FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device

Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

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