On August 27, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the European Commission has granted Marketing Authorization for PADCEV (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy (Press release, Astellas Pharma, AUG 27, 2024, View Source [SID1234646114]).

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The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.1

Dr. Thomas Powles, Barts Cancer Institute Biomedical Research Centre, UK
"Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase 3 clinical trial program, with enfortumab vedotin in combination with pembrolizumab significantly extending overall survival and progression-free survival compared to platinum-containing chemotherapy. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting."

Alex Filicevas, Executive Director, World Bladder Cancer Patient Coalition
"Despite Europe having the highest reported rates of new bladder cancer cases in the world, awareness remains low, resulting in many patients only being correctly diagnosed at the stage of advanced disease. New treatment options are desperately needed to improve disease outcomes for these patients and provide hope for a better future for the whole bladder cancer patient community."

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas
"In line with the recent updates to European clinical guidelines, we are delighted that the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer. This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community. We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey."

Bladder cancer is the fifth most commonly diagnosed cancer across the European region.2 Every year, more than 165,000 people are diagnosed with the disease and it claims the lives of over 50,000 people in the European Union (EU).3 Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor.4,5

The Phase 3 EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). The median PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice.1 Results were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in the New England Journal of Medicine.1

The European Marketing Authorization is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to recently updated clinical guidelines from the European Society for Medical Oncology and European Association of Urology which recommend enfortumab vedotin in combination with pembrolizumab as first-line treatment for locally advanced or metastatic urothelial cancer.6,7 Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit are able to access the treatment combination as soon as possible.

The approval follows the December 2023 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC by the U.S. Food and Drug Administration (FDA), and the European Commission approval of enfortumab vedotin as a monotherapy for the treatment of adult patients with la/mUC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in April 2022.8,9

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

For more information, please see the press release "Astellas Receives Positive CHMP Opinion for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer" issued on July 29, 2024.

About EV-302
EV-302 is an ongoing, open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The trial enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety.1

The most common (≥3%) Grade 3 or higher adverse events related to treatment with enfortumab vedotin and pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. The safety results in EV-302 are consistent with those previously reported with this combination in EV-103 in cisplatin-ineligible patients with la/mUC. No new safety issues were identified.1

The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and were published in the New England Journal of Medicine.1

For more information on the EV-302 trial (NCT04223856) go to View Source

About Bladder and Urothelial Cancer
Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs.10 Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.11,12 If cancer is not able to be treated with surgery, it is called unresectable.13 If cancer has spread to surrounding organs or muscles, it is called locally advanced disease.14 If cancer has spread to other parts of the body, it is called metastatic disease.15 Approximately 12% of cases are unresectable locally advanced or metastatic urothelial cancer at diagnosis.4

Bladder cancer is diagnosed in approximately 614,000 people and causes 220,000 deaths worldwide each year.16 In Europe, bladder cancer is the fifth most common cancer; more than 165,000 people are diagnosed with the disease in the EU each year.2,3 Continuous treatment and surveillance makes bladder cancer one of the most expensive cancer types over the lifetime of a patient and, in fact, have been shown to be the costliest cancer when compared to other malignancies.17

About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.9,18 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).9

PADCEV is indicated in the EU as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and in combination with KEYTRUDA (pembrolizumab) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.9

Ongoing Investigational Trials
EV-302 (NCT04223856) is an open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC) who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

EV-103 (NCT03288545) is an ongoing, multi-cohort, open-label, multicenter Phase 1b/2 trial investigating enfortumab vedotin alone or in combination with pembrolizumab and/or chemotherapy in first- or second-line settings in patients with la/mUC and in patients with muscle-invasive bladder cancer (MIBC).

Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905). The use of enfortumab vedotin in combination with pembrolizumab in second-line urothelial cancer and MIBC has not been proven safe or effective.

EV-203 (NCT04995419) is a Phase 2, multicenter, single-arm bridging trial in China designed to evaluate the efficacy, safety, and pharmacokinetic performance of enfortumab vedotin as treatment for patients in China. A total of 40 patients were enrolled in the trial.

EV-104 (NCT05014139) is a Phase 1 trial exploring enfortumab vedotin in patients with non-muscle invasive bladder cancer (NMIBC). The trial will be conducted in two-parts, assessing dose escalation and dose expansion with enfortumab vedotin when administered intravesically as a monotherapy.

EV-202 (NCT04225117) is an ongoing, multi-cohort, open-label, multicenter Phase 2 trial investigating enfortumab vedotin alone in patients with previously treated advanced solid tumors. This trial also has a cohort that is investigating enfortumab vedotin in combination with pembrolizumab in patients with previously untreated recurrent / metastatic head and neck squamous cell carcinoma.

Important Safety Information
For Important Safety Information for enfortumab vedotin please see the full Summary of Product Characteristics at: View Source

On August 27, 2024 (the "Closing Date"), Arcus Biosciences, Inc. (the "Company") reported to have entered into a Loan and Security Agreement (the "LSA"), by and among the Company, the several banks and other financial institutions or entities party thereto, as lenders, and Hercules Capital, Inc. ("Hercules"), as administrative agent and collateral agent (Filing, 8-K, Arcus Biosciences, AUG 27, 2024, View Source [SID1234646113]).

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The LSA provides a secured term loan facility of up to $250.0 million (collectively, the "Term Loans"), consisting of: (a) an initial $50.0 million tranche of term loans, which was funded on the Closing Date; (b) an additional tranche of term loans in an aggregate amount of $50.0 million that is available at the Company’s sole option, subject to customary terms and conditions, through June 15, 2025; (c) an additional tranche of term loans in an aggregate amount of $50.0 million that is available at the Company’s sole option, subject to customary terms and conditions, through March 15, 2026 (the amounts listed in (a), (b) and (c) above, the "Initial Tranches") and (d) an additional tranche of term loans in an aggregate amount of $100.0 million (the "Final Tranche"), which will be available at the lenders’ sole option, subject to customary terms and conditions, in $25.0 million increments. On the Closing Date, the Company paid an initial facility charge for the Initial Tranches equal to $1.125 million.

Borrowings under the LSA bear interest at a per annum rate equal to: (a) in cash, the greater of either (i) the Prime Rate (as reported in the Wall Street Journal) plus 1.95% and (ii) 10.45%. The Term Loans are repayable in monthly interest-only payments until September 1, 2028 (the "Interest-Only Payment Period"). The Company may extend the Interest-Only Payment Period an additional 12 months if (i) no default or event of default exists under the LSA and (ii) by August 27, 2028, the U.S. Food and Drug Administration has approved either a Biologics License Application or New Drug Application ("Milestone I"). After the expiration of the Interest-Only Payment Period, the Term Loans are repayable in equal monthly payments of principal and accrued interest until maturity.
The Term Loans will mature on September 1, 2029 (the "Maturity Date"). The Company may extend the Maturity Date up to an additional 12 months if (i) no default or event of default exists and (ii) the Company has accomplished two of the following events ("Milestone II"): (a) dosing the first patient in a pivotal phase 3 study of casdatifan for the treatment of renal cell carcinoma; (b) dosing the first patient in a pivotal phase 3 study of quemliclustat in patients with advanced pancreatic cancer; or (c) dosing the first patient in a pivotal phase 3 study of etrumadenant in patients with metastatic colorectal cancer.

At the Company’s option, the Company may prepay all or a portion of the outstanding Term Loans, subject to a prepayment premium equal to (a) 3.0% of the Term Loans being prepaid if the prepayment occurs during the 12 months following the Closing Date; (b) 2.0% of the Term Loans being prepaid if the prepayment occurs after the 12 month anniversary of the Closing Date but on or prior to the 24 month anniversary of the Closing Date; and (c) 1.0% of the Term Loans being prepaid if the prepayment occurs at least 24 months following the Closing Date and prior to the Maturity Date. In addition, the Company will pay an end of term charge of 7.75% upon the prepayment or repayment of the Term Loans and a facility charge of 0.75% upon any draws of the Term Loans from the Final Tranche.

The Term Loans are secured by a lien on substantially all of the assets of the Company other than any assets subject to an option held by Gilead Sciences, Inc. or Taiho Pharmaceutical Co., Ltd. The LSA includes a financial covenant that requires the Company to maintain, at all times during which the Company’s market capitalization is at or below $1.20 billion, "Qualified Cash" (defined as cash in accounts subject to control agreements minus any accounts payable not paid after the 120th day) in an amount greater than or equal to the outstanding principal amount of the Term Loans, multiplied by 50% (the "Qualified Cash Requirement Threshold"). The Qualified Cash Requirement Threshold will be decreased (a) to 40% upon accomplishing Milestone I and (b) to 35% upon accomplishing Milestone II.
In addition, the LSA includes customary affirmative and negative covenants and representations and warranties, including a covenant against the occurrence of a "change in control," financial reporting obligations, and certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, transfers, mergers or acquisitions, taxes, corporate changes, and bank accounts. The LSA also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a "material adverse effect" as set forth in the LSA, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the LSA.

The foregoing is only a brief description of the material terms of the LSA does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to such agreement, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024.

On August 27, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the publication in the Journal for ImmunoTherapy of Cancer (JITC) of a peer-reviewed article which illustrates that TG6050 induces profound immune remodeling of the tumor microenvironment in animal models (Press release, Transgene, AUG 27, 2024, View Source [SID1234646104]). The paper highlights TG6050’s potential to induce sustained intratumoral expression of interleukin-12 (IL-12) and anti-cytotoxic T-lymphocyte associated antigen-4 (CTLA-4) antibody at active concentrations without the toxicity observed with systemic administration.

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TG6050 is an oncolytic virus derived from Transgene’s invir.IO platform encoding interleukin-12 (IL-12) and an anti-CTLA4 antibody, with the potential to trigger a powerful localized antitumor immune response.

The JITC paper reports that in addition to consistent multiplication and propagation of TG6050 in tumor cells, functional transgenes are expressed in the tumor with a sustained intratumoral accumulation of IL-12 and anti-CTLA-4 antibody. The three components of TG6050 (oncolytic viral backbone, IL-12 and anti-CTLA-4 antibody transgenes) act together to induce tumor regression in numerous "hot" and "cold" murine tumor models investigated in these studies. This antitumoral activity was further amplified when TG6050 was combined with an anti-PD1.

Moreover, these studies show that TG6050 triggers a strong adaptive antitumoral immune response, accompanied by a profound modification of the tumor microenvironment based on infiltration of both innate and adaptive immune cells, altering it to a more inflamed state (from "cold" to "hot").

TG6050 was also shown to be safe. Upon intravenous administration in non-human primates for toxicology evaluation, it did not induce any of the IL-12 related adverse effects that are associated with systemic administration. TG6050 has now progressed into Phase 1 clinical development (the Delivir trial) in metastatic non-small cell lung cancer (NCT05788926).

"These strong preclinical data demonstrate the ability of our invir.IO oncolytic virus platform to generate promising candidates for further development and support our decision to advance TG6050 into the clinic in metastatic non-small cell lung cancer. We have thoroughly explored the mechanism of action of TG6050, with local delivery of functional IL-12 and anti-CTLA-4 resulting in strong antitumor activity. Moreover, in toxicology studies after repeated intravenous administrations in non-human primates, TG6050 did not display any observable adverse effects," commented Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

The JITC paper is titled "TG6050, an oncolytic vaccinia virus encoding interleukin-12 and anti-CTLA-4 antibody, favors tumor regression via profound immune remodeling of the tumor microenvironment" and can be accessed here.

About TG6050

TG6050 is an oncolytic virus developed with Transgene’s invir.IO platform for intravenous administration. invir.IO viruses are based on the patented large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK-RR- (VVCOPTK-RR-). TG6050 has been engineered to encode human IL-12, a cytokine that triggers a powerful antitumor immune response and a full length anti-CTLA4 antibody. It has also been optimized with the deletion of the gene encoding for the M2L viral protein that targets CD80 and CD86, two ligands of CD28 [source: Kleinpeter et al., J Virol. 2019 Jun 1 ; 93(11) : e00207-19]. The use of an oncolytic virus to deliver these immunotherapies locally and selectively in the tumor microenvironment allows high intratumoral concentrations of both therapeutic proteins eliciting a stronger and more effective antitumor response. By reducing systemic exposure to a very low level, this local therapeutic activity furthermore allows an increase in the safety and tolerability profile of IL-12 and the anti-CTLA4 antibody.

TG6050 is being evaluated in the Deliver trial, a Phase I trial conducted in advanced non-small cell lung cancer (NSCLC) patients.

About the Delivir trial (NCT: 05788926)

The Delivir trial is a multicenter, open label, dose-escalation Phase I trial evaluating TG6050 as a single agent. The trial will enroll up to 36 patients with metastatic/advanced NSCLC, who have failed standard therapeutic options including immunotherapies such as immune checkpoint inhibitors. Patients will receive single and repeated escalating doses of TG6050 administered intravenously, to determine the recommended dose and best schedule of administration for subsequent clinical development.

On August 27, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported dosing of the first patient in the HIGHLIGHT 1 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy (Press release, Astellas, AUG 27, 2024, View Source [SID1234646103]).

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Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022.1 Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies,2 most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats.3

Marci English, Vice President, Head of BioPharma Development, Astellas
"VMS can adversely affect quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients."

About HIGHLIGHT 1
HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks.

About Fezolinetant
Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. VMS are also known as hot flashes or night sweats. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.4,5,6 There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

On August 26, 2024 The South Korean biotech company GI Innovation reported that it has signed a clinical trial collaboration and supply agreement with MSD (a tradename of Merck& Co., Inc., Rahway, NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma (Press release, GI Innovation, AUG 26, 2024, View Source [SID1234646110]).

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This agreement marks GI Innovation’s second clinical trial collaboration with MSD, following a previous collaboration for GI-101A.

The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options. GI Innovation is focused on three indications with significant market potential and potential likelihood of success: metastatic liver cancer, melanoma, and renal cell carcinoma. The company has already demonstrated strong anti-cancer efficacy with a 42.9% overall response rate (ORR) in a monotherapy trial of GI-102 in melanoma patients who failed to respond to standard-of-care treatment (3 partial responses out of 7 patients). Complete tumor regression was previously observed in 60% of mice treated with GI-102 monotherapy in a preclinical liver cancer model.

Fourteen hospitals in South Korea and world-renowned sites in the U.S. have agreed to join the trial, including the Mayo Clinic (campuses in Rochester, Florida, and Arizona), Cleveland Clinic and Memorial Sloan Kettering Cancer Center. In South Korea, the trial will take place at leading hospitals including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital.

"We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy", said Dr Myung-Ho Jang, GI Innovation’s Chief Scientific Officer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.