FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act Action (PDUFA) Date of
Positive Regulatory Feedback Supports Lifileucel Regulatory Submissions in
Onboarding Completed at Approximately 30 Authorized Treatment Centers (ATCs) in Preparation for Potential
Recent and Third Quarter 2023 Highlights and Corporate Updates
Lifileucel in Advanced Melanoma
- The BLA Priority Review remains on track for lifileucel for patients with advanced melanoma with a PDUFA date of
February 24, 2024. Iovance continues to work with the FDA to expedite approval of lifileucel in advance of the PDUFA date. All pre-approval inspections of clinical sites, internal and external manufacturing, and testing facilities have been successfully completed.
- Following lifileucel’s initial
U.S.launch, Iovance’s expansion strategy is expected to more than double the total addressable advanced melanoma patient population for lifileucel. Iovance has recently made significant progress toward the goal of bringing lifileucel to new geographies:
- Following recent positive feedback from the
European Medicines Agency(EMA) on Cohorts 2 and 4 of the C-144-01 clinical trial, Iovance plans to submit a marketing authorization application (MAA) in the European Unionfor lifileucel in advanced melanoma in the first half of 2024.
- Iovance is also engaged with the Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom( U.K.) and Health Canada. Iovance also plans to submit an MAA for lifileucel in the U.K.and a new drug submission (NDS) in Canadain the second half of 2024.
- Additional regulatory submissions for lifileucel are planned for
Australiaand other countries with significant populations of advanced melanoma patients.
- Following recent positive feedback from the
- Patient enrollment and global site activation continue in the registrational Phase 3 TILVANCE-301 trial to support accelerated and full approvals of lifileucel in combination with pembrolizumab in frontline advanced melanoma. Recent site activations include additional
U.S.sites and the first site in Australia, with regulatory clearances obtained to open sites in the U.K.and Canada. TILVANCE-301 is a confirmatory trial to support full approval of lifileucel in post-anti-PD-1 advanced melanoma. TILVANCE-301 remains on track to be well underway at the time of potential accelerated approval for lifileucel in this initial indication.
- A subanalysis from the C-144-01 trial of patients with advanced mucosal melanoma was presented at the
European Society for Medical Oncology (ESMO) Congress2023, October 20-24, 2023, Madrid, Spain. In these difficult-to-treat patients, a confirmed objective response rate (ORR) of 50.0% was observed, with 67% of responses ongoing at 24+ months.
Manufacturing and Commercial Preparations
- Pre-approval onboarding steps to treat melanoma patients with lifileucel upon approval have been completed at approximately 30 ATCs. Approximately 50 ATCs are expected to be onboard within 90 days of the PDUFA date, demonstrating the strong excitement and demand in the melanoma community for the launch of lifileucel. The Iovance team is partnering with ATCs to build their TIL service lines and working with payers to speed reimbursement. Iovance expects rapid uptake of lifileucel in the U.S. market in 2024 given the extensive commercialization, manufacturing, patient access, and reimbursement preparations, as well as the lack of alternative options for advanced melanoma patients. Following the ongoing successful integration of the Proleukin® acquisition, significant revenue increases from the Proleukin® business are also expected in 2024.
- To date, more than 600 patients have been treated with Iovance TIL therapy manufactured using proprietary Iovance processes, with a manufacturing success rate of more than 90%.
- The Iovance Cell Therapy Center (iCTC) is currently manufacturing TIL therapies for clinical trials while executing activities to support BLA review in preparation for initiating commercial supply. The iCTC facility currently has annual capacity to supply TIL therapies for 2,000+ patients, with buildable shell space to ultimately supply TIL therapies for 5,000+ patients. Iovance also has additional contract manufacturing flexibility and capacity to meet potential commercial and clinical demand.
Iovance TIL Therapy in Advanced Non-Small Cell
- Registrational Phase 2 Trial IOV-LUN-202 in Post-Anti-PD-1 NSCLC: Enrollment in IOV-LUN-202 is ongoing at more than 40 clinical sites in the U.S., Canada, and Europe, and is on track to be completed in the second half of 2024. There is strong physician interest and momentum for center participation following the positive preliminary data analysis and FDA regulatory feedback that the design of the single-arm IOV-LUN-202 trial may be acceptable for approval of LN-145 TIL therapy in post-anti-PD-1 NSCLC.
- NSCLC Clinical Trial Regulatory Update: Iovance is planning to meet with the FDA in early 2024 to discuss a potential registrational trial of lifileucel in combination with pembrolizumab after standard of care chemotherapy to serve as the confirmatory trial for IOV-LUN-202 in post-anti-PD-1 melanoma and to support accelerated approval in frontline advanced NSCLC.
- Iovance TIL Therapy in Combination with Anti-PD-1 in Frontline Advanced NSCLC: Detailed results from Cohort 3A of the IOV-COM-202 clinical trial, exploring TIL in combination with pembrolizumab in anti-PD-1 naïve advanced NSCLC patients, were presented at an oral session during the IASLC 2023
World Congress on Lung Cancer(WCLC 2023).
Iovance TIL Therapy in Endometrial Cancer
- Iovance is expanding its robust clinical portfolio with a new TIL therapy program in post-anti-PD-1 and post-chemotherapy advanced endometrial cancer. Advanced endometrial cancer represents a significant opportunity for TIL therapy, with no currently approved therapies in the emerging second-line setting, post-anti-PD1 therapy and chemotherapy. A Phase 1/2 study in mismatch repair (MMR) deficient and MMR proficient patient populations is expected to commence in the first half of 2024. More than 10,000 women are expected to die in the
U.S.in 2023 from endometrial cancer, representing a significant patient population with unmet medical need.1
Additional Pipeline Highlights
- Additional clinical trials of Iovance TIL therapies include IOV-GM1-201 to investigate PD-1 inactivated TIL therapy (IOV-4001) in previously treated advanced melanoma or NSCLC as well as pivotal Cohort 2 in the ongoing C-145-04 trial of lifileucel to support a BLA in cervical cancer following progression on or after chemotherapy and pembrolizumab.
- A novel interleukin-2 (IL-2) analog (IOV-3001) is in Investigational New Drug (IND)-enabling studies supporting its use as part of the TIL treatment regimen following TIL infusion.
- Additional research and preclinical studies are exploring approaches to increase TIL potency using CD39/69 double negative TILs and stable gene incorporation enhancements such as tethered cytokines.
- As of
September 30, 2023, Iovance’s unaudited cash position is approximately $427.8 million. Following strategic portfolio prioritization, as well as completion of many one-time commercial and manufacturing readiness activities, quarterly and annual operating expenses are expected to be reduced in the remainder of 2023 and 2024, while continuing all key clinical programs and utilizing internal manufacturing capabilities.
- Iovance currently owns more than 60 granted or allowed U.S. and international patents for TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity into 2038. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.
Third Quarter and Year-to-Date Financial Results
Net loss for the third quarter ended
Revenue for the third quarter and nine months ended
Research and development expenses were $87.5 million for the third quarter ended September 30, 2023, an increase of $15.0 million compared to $72.5 million for the same period ended September 30, 2022. Research and development expenses were
The increases in research and development expenses in the third quarter and the nine months ended
Selling, general and administrative expenses were $27.0 million for the third quarter ended September 30, 2023, a decrease of $0.9 million compared to $27.9 million for the same period ended September 30, 2022. Selling, general and administrative expenses were
The decrease in selling, general and administrative expenses in the third quarter and the nine months ended
Webcast and Conference Call
To participate in the conference call Q&A and live audio webcast, please register at https://register.vevent.com/register/BIfd1787749ef747f19a491cb371d60fab. To listen to the live or archived webcast, please register at https://edge.media-server.com/mmc/p/n9gmq93h. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will be available for one year.
About Iovance Biotherapeutics, Inc.
Certain matters discussed in this press release are “forward-looking statements” of
Selected Condensed Consolidated Balance Sheets
|Cash, cash equivalents, and investments||$||361,374||$||471,845|
|Condensed Consolidated Statements of Operations
(unaudited; in thousands, except per share information)
|For the Three Months Ended||For the Nine Months Ended|
|Costs and expenses*|
|Cost of sales||$||4,340||$||—||$||6,390||$||—|
|Research and development||87,526||72,502||256,607||214,208|
|Selling, general and administrative||26,964||27,893||77,013||77,634|
|Total costs and expenses||118,830||100,395||340,010||291,842|
|Loss from operations||(118,361)||(100,395)||(339,303)||(291,842)|
|Interest income, net||3,358||777||9,925||1,268|
|Net Loss before income taxes||$||(115,003)||$||(99,618)||$||(329,378)||$||(290,574)|
|Income tax benefit||1,243||—||1,720||—|
|Net Loss Per Share of Common Stock, Basic and Diluted||$||(0.46)||$||(0.63)||$||(1.44)||$||(1.85)|
|Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted||245,817||157,817||228,115||157,404|
|*Includes stock-based compensation as follows:|
|Research and development||$||8,787||$||11,272||$||27,036||$||38,863|
|Selling, general and administrative||7,034||8,508||21,190||25,650|
|Total stock-based compensation included in costs and expenses||$||15,821||$||19,780||$||48,226||$||64,513|
SVP, Investor Relations & Corporate Communications
650-260-7120 ext. 264
Director, Investor Relations & Public Relations
1 American Cancer Statistics. Key Statistics for Endometrial Cancer, https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html.
Source: Iovance Biotherapeutics, Inc.