On September 16, 2024 Johnson & Johnson (NYSE: JNJ) reported interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and scheduled for radical cystectomy (RC) (Press release, Johnson & Johnson, SEP 16, 2024, View Source [SID1234646627]). These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress (Abstract #LBA84).

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"These findings from the SunRISe-4 study show for the first time that an intravesical treatment with TAR-200, combined with a systemic PD-1 inhibitor, could potentially result in a complete pathological response in a high proportion of patients, as well as allowing a tolerable approach," said Andrea Necchi, M.D., of Italy’s Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute and a presenting author of the study. "These preliminary findings show a potential for a future change in the local treatment of muscle-invasive bladder carcinoma using TAR-200."

In the interim analysis of the SunRISe-4 study, neoadjuvant TAR-200 plus CET (n=53) showed overall efficacy with a centrally confirmed pathologic complete response (pCR, [T0]) rate of 42 percent compared to 23 percent (95 percent CI, 28-56; 10-41, respectively) with CET alone (n=31) in patients with histologically proven, non-metastatic MIBC. The pathological overall response (pOR) rate (defined as the proportion of patients ≤ pT1) was 60 percent compared to 36 percent, respectively (CI 95 percent, 46-74; 19-55).1

In a subgroup analysis of patients with organ-confined disease (cT2), those treated with TAR-200 plus CET (n=40) showed a 48 percent pCR rate compared to 23 percent pCR with CET alone (n=26, 95 percent CI, 32-64; 9-44, respectively) and 68 percent were downstaged (≤ pT1) at the time of radical cystectomy, potentially improving surgical outcomes and reducing risk of recurrence.1

"With these promising results, TAR-200 plus cetrelimab as a neoadjuvant therapy before radical cystectomy could potentially alter how bladder cancer is treated," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Innovative Medicine, Johnson & Johnson. "This investigational innovative approach may offer a possible alternative for many patients who are not eligible for the current standard of pre-operative treatments."

Treatment-related adverse events (TRAEs) occurred in 72 percent of patients treated with TAR-200 combined with CET and 44 percent of patients treated with CET alone, with the majority being Grade 1-2. Nine percent of patients discontinued treatment with TAR-200 and eight percent discontinued treatment with CET in the combined treatment cohort due to TRAEs; no patients discontinued treatment due to TRAEs when treated with CET alone.1

Bladder cancer is the ninth most common cancer in the world.2 Although BCG immunotherapy has been accepted as the standard of care for nearly five decades, 30-40 percent of patients do not respond to BCG and experience disease recurrence or progression.3 In such scenarios, radical cystectomy (removal of the bladder and neighboring structures and organs) emerges as the primary treatment option. This major abdominal procedure requires a urinary diversion to be created to collect and store urine.4

TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder. It is installed in a physician’s office setting during a 2-3 minute procedure with no anesthesia. In December 2023, the FDA granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with BCG-unresponsive HR-NMIBC, who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder).

About SunRISe-4
SunRISe-4 (NCT04919512) is an open-label, multicenter, randomized Phase 2 study assessing the efficacy and safety of neoadjuvant TAR-200 + cetrelimab (CET) (anti-programmed death-1 antibody) or neoadjuvant CET alone in patients with MIBC scheduled for RC who are ineligible for or refuse neoadjuvant platinum-based chemotherapy.

About TAR-200
TAR-200 is an investigational targeted releasing system, enabling extended release of gemcitabine into the bladder, increasing the amount of time the drug delivery system spends in the bladder and sustaining local drug exposure. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with MIBC in SunRISe-2 and SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5.

About Cetrelimab
Cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment. Cetrelimab is also being evaluated in multiple other combination regimens.

About Muscle-Invasive Bladder Cancer
Muscle-invasive bladder cancer (MIBC) is a severe form of bladder cancer where the tumor penetrates the muscular layer of the bladder wall, significantly increasing the risk of metastasis.5 Approximately 25 percent of bladder cancer cases are diagnosed as MIBC at the time of initial presentation.6 Early detection and timely intervention are crucial for managing MIBC, as delayed treatment can lead to poor prognosis.

On September 16, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, reported the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM) (Press release, Delcath Systems, SEP 16, 2024, View Source [SID1234646648]). The data were presented by Dr. Matthew Wheater from University Hospital Southampton at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona.

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The FOCUS trial was a pivotal Phase 3 study designed to evaluate the efficacy and safety of HEPZATO KIT in patients with unresectable hepatic metastases from mUM. The primary endpoint of the study was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS). The trial enrolled 102 patients, of whom 91 received treatment. The full results of the FOCUS trial were published on May 4, 2024, in the Annals of Surgical Oncology.

The subgroup analysis evaluated patients with and without extrahepatic disease, treatment-naive versus previously treated patients, and those with low (1-25%) versus high (26-50%) liver tumor burden. There were no significant differences in OS, ORR, or PFS between patients with and without extrahepatic lesions or based on prior therapy. While ORR and PFS remained consistent regardless of liver tumor burden, more extensive liver involvement was associated with worse OS outcomes.

Objective tumor responses were observed throughout the entire treatment period; the earliest following completion of the first treatment cycle, and the latest following treatment cycle 6. This result supports the strategy to continue treatment until best response is achieved. Rates of serious adverse events (SAEs) and Grade 3/4 adverse events (AEs) remained consistent, indicating an absence of cumulative toxicity. These findings underscore the favorable benefit-risk profile of HEPZATO KIT in this patient population, offering a meaningful option for patients who typically have limited treatment options.

Dr. Wheater commented, "The lack of significant differences in outcomes between patients with and without extrahepatic disease is encouraging, particularly for a liver-directed therapy like Melphalan/HDS. Additionally, the fact that responses were observed through all six treatment cycles supports the strategy of continuing treatment beyond two cycles in patients with stable disease."

On September 16, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational stem cell memory T cell (TSCM)-based allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with relapsed/refractory multiple myeloma (Press release, Poseida Therapeutics, SEP 16, 2024, View Source [SID1234646681]).

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RMAT designation includes all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. Poseida’s RMAT application was evaluated based on encouraging early data from its ongoing Phase 1 study of P-BCMA-ALLO1, which demonstrated P-BCMA-ALLO1’s potential to offer promising efficacy, safety profile and rapid ‘off-the-shelf’ patient access.

"The RMAT designation for P-BCMA-ALLO1, our lead program, is based on impressive early clinical data from our ongoing Phase 1 study and further validates its potential to address the unmet needs of patients with relapsed/refractory multiple myeloma," said Kristin Yarema, Ph.D., president and chief executive officer of Poseida Therapeutics. "Importantly, our data has shown clinical responses in very sick, refractory patients, including those that have received prior BCMA-targeted therapies. With both RMAT and Orphan Drug designations for P-BCMA-ALLO1, we look forward to working closely with the FDA as we continue to advance this next-generation, off-the shelf allogeneic CAR-T therapy, including the recently initiated Phase 1b portion of the trial."

The Company will report new clinical data from the P-BCMA-ALLO1 Phase 1 study in an oral session at the 21st International Myeloma Society Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024. Additional clinical updates are planned for the second half of 2024, subject to coordination with Roche, which has a strategic collaboration with Poseida covering multiple investigational allogeneic CAR-T therapies targeting blood cancers, including P-BCMA-ALLO1.

The RMAT designation is a program under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such disease or condition.

RMAT designation includes all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints. RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional sites, as appropriate.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH (Free ASH Whitepaper) in December 2023 support the Company’s belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. The FDA has granted P-BCMA-ALLO1 Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and anti-CD38 antibody in addition to Orphan Drug designation for multiple myeloma. Additional information about the Phase 1/1b study is available at www.clinicaltrials.gov using identifier: NCT04960579.

On September 16, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported positive one-year data from the ongoing phase 2 trial with its lead asset EVX-01, an AI-designed personalized cancer vaccine (Press release, Evaxion Biotech, SEP 16, 2024, View Source [SID1234646649]).

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"We are thrilled to present this groundbreaking data, which underscores the significant therapeutic potential of EVX-01. Among several promising individual data points, the 69% Overall Response Rate (ORR) is particularly impressive and encouraging. Building on an already strong data package for EVX-01, these new findings strengthen our confidence that we can meaningfully improve treatment options for advanced melanoma," says Birgitte Rønø, CSO of Evaxion.

"The clinical findings are another validation of our AI-Immunology platform as a leading AI technology for fast and effective vaccine target discovery and design and clearly positions us as a leader in the field of AI immunology. The observed reduction in tumors in 15 out of 16 patients is offering great hope for patients with melanoma. We are looking very much forward to engaging with stakeholders to present the compelling clinical profile of EVX-01 as a transformative personalized cancer vaccine," says Christian Kanstrup, CEO of Evaxion.

The data stems from a one-year interim analysis of the ongoing phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). The data was presented during the weekend at a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain.

Unique profile of EVX-01 supported by both clinical efficacy and immune data
The data demonstrates 69% ORR, reduction in tumor target lesions in 15 out of 16 patients, an immunogenicity rate of 79%, and a positive correlation between Evaxion’s AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Neoantigens are newly formed antigens generated from cancer-specific mutations. As a neoantigen vaccine, EVX-01 aims at triggering the patient’s immune system to target these specific antigens and thereby eradicate the cancer cells.

The 69% ORR is calculated based on 11 out of 16 patients in the trial having objective clinical responses. This rate may increase as more data are collected but will not decrease. Final results are expected in the third quarter of 2025.

Further to the encouraging clinical data, the immunogenicity data from the trial are also impressive, demonstrating that 79% of EVX-01’s neoantigens triggered a targeted immune response. This immunogenicity rate stands out as unprecedented compared to historical observations and compares very favorably to what is seen with other approaches. It also underlines and validates the precision of the AI-Immunology platform in identifying neoantigens which leads to detectable signals in patients.

The new data also confirms the strong predictive capabilities of AI-Immunology with a positive correlation between its predictions and the neoantigen immune response detected in the patients with a p-value of p=0.00013. In other words, the data confirms that the neoantigens identified by the platform as the most relevant vaccine targets are also the ones that trigger specific immune responses in patients.

Significant commercial potential
The global burden from melanoma is estimated to increase to 510,000 new cases and 96,000 deaths by 2040 (Arnold et al., JAMA Dermatology 2022), and the global market for melanoma treatments is estimated to grow to $7.4 billion by 2029 (GlobalData).

Considering the prevalence of the disease and the size of the market, the development of EVX-01 as a novel potential melanoma treatment holds a significant commercial potential for Evaxion. As EVX-01 is also thought to have the potential to treat several other solid tumor cancers, the total commercial opportunity could be further enhanced by expanding into other indications.

Webinar on September 18

Evaxion will be hosting an online webinar featuring key opinion leader and the trial’s principal investigator, Professor Georgina V. Long, on September 18, 2024, at 19.00 CEST/13.00 EDT. The webinar can be attended through registration via this link.

In the webinar, Professor Long will present the data from the one-year interim analysis and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.

About EVX-01

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed Phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

About EVX-01 phase 2 clinical trial

The Phase 2 clinical study (NCT05309421) is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with leading principal investigators and research centers from Italy and Australia. The trial aims to evaluate the efficacy and safety of EVX-01 vaccination in combination with MSD’s anti-PD1 therapy KEYTRUDA (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Merck Sharp & Dohme LLC supplies KEYTRUDA (pembrolizumab) for the trial.

On September 16, 2024 Novartis reported an updated analysis from the pivotal Phase III NATALEE trial, investigational Kisqali (ribociclib) added to endocrine therapy (ET) shows a deepening benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5% (HR=0.715; 95% CI 0.609–0.840; P<0.0001), compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (Press release, Novartis, SEP 16, 2024, View Source [SID1234646666]). This invasive disease-free survival (iDFS) benefit was also consistent across all pre-specified patient subgroups, including those with node-negative disease1. Late-breaking data from this four-year post-hoc analysis will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024.

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iDFS benefit across pre-specified subgroups1:

Subgroup 4-year iDFS rate, % 4-year iDFS absolute benefit, %
Intention-To-Treat Population Kisqali + ET: 88.5
ET alone: 83.6
(HR=0.715; 95% CI 0.609–0.840) 4.9
AJCC Tumor Stage II Kisqali + ET: 93.9
ET alone: 89.6
(HR=0.644; 95% CI 0.468–0.887) 4.3
AJCC Tumor Stage III Kisqali + ET: 84.3
ET alone: 78.4
(HR=0.737; 95% CI 0.611–0.888) 5.9
Node-negative disease Kisqali + ET: 92.1
ET alone: 87.0
(HR=0.666; 95% CI 0.397–1.118) 5.1
Results were also consistent across secondary efficacy endpoints, including distant disease-free survival (HR=0.715; 95% CI 0.604–0.847; P<0.0001), with a trend for improvement in overall survival (HR=0.827; 95% CI 0.636–1.074; one-sided P value=0.0766)*1.

"Clinicians are eager to address the substantial risk of cancer coming back as metastatic disease for patients diagnosed with HR+/HER2- early-stage breast cancer," said Peter A. Fasching, M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. "With longer follow-up, the clinically relevant benefit of adding ribociclib to endocrine therapy continues to improve, even after the end of ribociclib treatment, for both node-positive and node-negative patients. This is important because NATALEE includes a broad population of patients at risk of recurrence, including those diagnosed with high-risk, node-negative disease who deserve access to new treatment options to reduce that risk."

Safety remains consistent with previously reported results with no new safety signals identified1. Adverse events (AEs) of special interest (grade 3 or higher) were neutropenia (44.4%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1.

"As we anticipate regulatory action from health authorities worldwide, we are highly encouraged by these longer-term results from NATALEE showing a deepening efficacy benefit for Kisqali," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "A large number of people diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence, and these results add to the growing body of evidence supporting the potential of Kisqali to reduce this risk consistently across a broad population, including patients with node-negative disease who have few options beyond ET."

Novartis submitted NATALEE data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2023, and FDA regulatory action is expected in Q3.

*Results based on overall survival analysis at time of 4-year post-hoc analysis; additional follow-up is planned to obtain more mature OS data.

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO4,5. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable4,5. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria4,5. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial4,5.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide, including in the U.S., EU and China.

Kisqali has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide, including by the U.S. FDA and the European Commission6,7. In the U.S., Kisqali is indicated for the treatment of adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men6. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression7. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist6,7.

In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials8-18. The NCCN Guidelines for breast cancer recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC19. 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 pre-menopausal patients with HR+/HER2- advanced breast cancer20. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line21.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

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