Elicio Therapeutics Announces First Patient Dosed in Phase 1/2 Study of Lymph Node-Targeted Investigational Therapeutic Vaccine ELI-002 7P (AMPLIFY-7P) in KRAS/NRAS Mutated Solid Tumors

On April 27, 2023 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the first patient has been dosed in the Phase 1/2 study of ELI-002 7P (AMPLIFY-7P) in KRAS/NRAS mutated solid tumors at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York (Press release, Elicio Therapeutics, APR 27, 2023, View Source [SID1234630604]).

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ELI-002 7P is an investigational therapeutic cancer vaccine that was created with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to treat cancers driven by seven common mutations in KRAS representing 25% of all solid tumors. Most other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors — target fewer mutations, potentially limiting the number of patients that can be treated.

Interim data from the AMPLIFY-201 study evaluating the 2-peptide formulation of ELI-002 in mKRAS pancreatic and colorectal cancer patients including the effects of dose on proof-of-concept safety, antitumor biomarkers, relapse-free survival, and immune mechanism of action endpoints is anticipated to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023.

"This key milestone highlights our expansion to more of the patient population with common KRAS and NRAS mutations who could potentially benefit from smart vaccines that engage the lymph node, the ‘brain center’ of the immune response," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Our clinical experience with AMP vaccines will be important to rapidly advance the development of broad-spectrum ELI-002 7P, targeting seven mutations G12D, G12V, G12R, G12C, G12S, G12A and G13D in patients with high relapse risk, KRAS-driven, cancers who have minimal residual disease following surgery and chemotherapy."

Robert Connelly, Elicio’s Chief Executive Officer, added, "The dosing of the first patient in AMPLIFY-7P, our second ongoing clinical trial, is a testament to the dedication of our team and study collaborators in exploring the potential of ELI-002 as a universal, all-stage immunotherapeutic for treating and preventing mKRAS-driven tumors. We believe there is a path for its use as a monotherapy and a combination therapy in different clinical settings, so we intend to move quickly, conducting a safety run-in bridging from the 2-peptide to the 7-peptide formulations before initiating the Phase 1b and randomized Phase 2 studies, which we hope will inform our plans for a combination trial and provide supporting evidence for expedited development pathways with regulatory agencies."

The current standard of care for patients who remain positive for a biomarker following surgery and initial treatment is observation to monitor for relapse, which has a near certain probability of occurring. In pancreatic ductal adenocarcinoma (PDAC) patients who have positive circulating tumor DNA (ctDNA) post-surgery, relapse occurs in 80%–85% of cases despite ‘curative’ resection with a median time of 9.9 months to recurrence. In colorectal cancer (CRC) patients who have positive ctDNA post-surgery, radiologic recurrence was detected in approximately 79% of cases with a Kaplan Meier estimate of 0% survival at 3 years. These relapse and recurrence rates highlight the great unmet need for novel therapies in this window of opportunity where patients are being monitored for progression by CT scans and standard therapies have already been completed.

About AMPLIFY-7P

AMPLIFY-7P (NCT05726864) is a Phase 1/2 study to assess the efficacy of ELI-002 7P a therapeutic cancer vaccine containing seven KRAS and NRAS peptide-based antigens (G12D, G12R, G12V, G12A, G12C, G12S, G13D). This study builds on existing data obtained from the ongoing AMPLIFY-201 trial. In Phase 1a the recommended Phase 2 dose of the immune stimulatory oligonucleotide (Amph-CpG-7909) will be evaluated in combination with two different dose levels of the seven-peptide formulation. Completion of Phase 1a will inform the recommended dose for Phase 1b and Phase 2 for ELI-002 7P. Phase 1b will feature three dose expansion cohorts and will evaluate preliminary evidence of biomarker response. The Phase 2 portion of the study will enroll additional patients and will be randomized 2:1 (ELI-002 7P vs observation) to further evaluate anti-tumor activity and will seek to determine whether ELI-002 7P improves relapse-free survival. Subjects randomized to the observation group will receive the same safety and efficacy evaluations and will also be able to elect to cross-over to ELI-002 7P treatment if disease progression is confirmed.

bluebird bio Announces First Quarter 2023 Earnings Date and Upcoming Investor Events

On April 27, 2023 bluebird bio, Inc. (Nasdaq: BLUE) reported that the Company’s first quarter financial results, including commercial, regulatory and operational updates, will be released pre-market on Tuesday, May 9 (Press release, bluebird bio, APR 27, 2023, View Source [SID1234630603]).

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In addition, members of the management team will participate in the following upcoming investor conferences:

BofA Securities 2023 Health Care Conference, Thursday, May 11, at 8:15 a.m. PT at the Encore Hotel, Las Vegas, NV
Goldman Sachs 44th Annual Global Healthcare Conference, Monday, June 12, at 4:40 p.m. PT at the Waldorf Astoria Monarch Beach Resort & Club, Dana Point, CA
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

Lilly Reports First-Quarter 2023 Financial Results, Highlights Continued Core Business Growth and Pipeline Momentum

On April 27, 2023 Eli Lilly and Company (NYSE: LLY) reported its financial results for the first quarter of 2023 (Press release, Eli Lilly, APR 27, 2023, View Source [SID1234630600]).

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"Core business growth drove solid first-quarter financial results and a strong start for Lilly in 2023, which includes pipeline progress led by positive SURMOUNT-2 data for tirzepatide in obesity," said David A. Ricks, Lilly’s chair and CEO. "We also announced important price reductions to make insulin more affordable and accessible for people with diabetes, as well as a significant investment in manufacturing facilities. It is an exciting year for Lilly and we look forward to delivering more medicines for unmet health needs to more people around the world."

Lilly has had numerous updates recently on key regulatory, clinical, business development and other events, including:

The announcement that tirzepatide achieved superior weight loss and met both co-primary objectives and all key secondary objectives compared to placebo at 72 weeks in the Phase 3 SURMOUNT-2 study;
The U.S. Food and Drug Administration’s (FDA) approval of an expanded indication for Verzenio, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence;
Price reductions of 70% for the company’s most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month;
The FDA’s issuance of a complete response letter for mirikizumab in ulcerative colitis, citing issues related to the proposed manufacturing of mirikizumab with no concerns about the clinical data package, safety or label;
The FDA’s acceptance of the supplemental New Drug Application for Jardiance for children 10 years and older with type 2 diabetes;
The announcement that the company will invest an additional $1.6 billion at its two new manufacturing sites in Indiana, bringing the company’s total commitment to $3.7 billion and up to 700 new jobs;
The agreement to sell the rights of the olanzapine portfolio, including Zyprexa, to Cheplapharm Arzneimittel GmbH for $1.05 billion in cash upon regulatory approval and successful closing of the transaction, with an additional $305 million in cash upon the one year anniversary of closing and milestone payments of up to $50 million.
The agreement to sell the rights of Baqsimi to Amphastar Pharmaceuticals, Inc. for $500 million in cash upon regulatory approval and successful closing of the transaction, with an additional $125 million in cash upon the one year anniversary of closing and milestone payments of up to $450 million.
The collaboration with International Agencies Ltd. to increase patient access and improve affordability for high-quality insulin for nearly one million people living with diabetes in Bangladesh by 2030.
For additional information on important public announcements, visit the news section of Lilly’s website.

Financial Results

$ in millions, except

per share data

First Quarter

2023

2022

% Change

Revenue

$6,960.0

$7,810.0

(11) %

Net Income – Reported

1,344.9

1,902.9

(29) %

EPS – Reported

1.49

2.10

(29) %

Net Income – Non-GAAP

1,463.9

2,372.8

(38) %

EPS – Non-GAAP

1.62

2.62

(38) %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

First-Quarter Reported Results

In Q1 2023, worldwide revenue was $6.96 billion, a decrease of 11% compared with Q1 2022, driven by a 5% decrease due to lower realized prices, a 4% decrease due to lower volume, and a 2% decrease from the unfavorable impact of foreign exchange rates. The decline in volume was driven by $1.47 billion in revenue from COVID-19 antibodies in Q1 2022. Excluding COVID-19 antibodies, revenue in Q1 2023 increased 10% and total worldwide volume increased 18%. New Products contributed $573.6 million to revenue in Q1 2023. Growth Products revenue increased 18% to $4.56 billion in Q1 2023.

Revenue in the U.S. decreased 14% to $4.44 billion, driven by a 10% decrease in volume and a 5% decrease due to lower realized prices. The decline in volume was driven by $1.46 billion in revenue from COVID-19 antibodies in Q1 2022. Excluding revenue from COVID-19 antibodies, revenue in the U.S. increased 19%, primarily driven by volume from Mounjaro, Trulicity and Verzenio, partially offset by decreased volume from Alimta due to the loss of patent exclusivity. The lower realized prices in the U.S. were primarily driven by Humalog and Trulicity.

Revenue outside the U.S. decreased 4% to $2.52 billion, driven by a 6% decrease from the unfavorable impact of foreign exchange rates and a 5% decrease due to lower realized prices, partially offset by a 7% increase in volume. The lower realized prices were primarily driven by the impact of government pricing in China from the volume-based procurement (VBP) for Humalog. The increase in volume outside the U.S. was largely driven by Verzenio and Jardiance and, to a lesser extent, Taltz, Trulicity and Mounjaro, partially offset by a decrease in Cialis volume due to the Q1 2022 sales of the company’s rights to Cialis in Taiwan and Saudi Arabia.

Gross margin decreased 7% to $5.33 billion in Q1 2023. Gross margin as a percent of revenue was 76.6%, an increase of 3.1 percentage points. The increase in gross margin percent was primarily driven by sales of COVID-19 antibodies in Q1 2022, partially offset by lower realized prices.

In Q1 2023, research and development expenses increased 23% to $1.99 billion, or 29% of revenue, primarily driven by higher development expenses for late-stage assets.

Marketing, selling and administrative expenses increased 12% to $1.75 billion in Q1 2023, primarily driven by costs associated with launches of new products and indications.

In Q1 2023, the company recognized acquired in-process research and development (IPR&D) charges of $105.0 million. In Q1 2022, the company recognized acquired IPR&D charges of $165.6 million, primarily related to a purchase of a Priority Review Voucher.

Other income (expense) was income of $35.7 million in Q1 2023 compared with expense of $350.7 million in Q1 2022. The increase in other income (expense) was primarily driven by net losses on investments in equity securities in Q1 2022.

The effective tax rate was 12.1% in Q1 2023 compared with 7.3% in Q1 2022. The effective tax rate in Q1 2023 reflects the tax impact of the new Puerto Rico tax regime, partially offset by a net discrete tax benefit. The effective tax rate in Q1 2022 reflected the favorable tax impact of net investment losses on equity securities.

In Q1 2023, net income and earnings per share (EPS) were $1.34 billion and $1.49, respectively, compared with $1.90 billion and $2.10 in Q1 2022. EPS in Q1 2023 was inclusive of $0.10 of acquired IPR&D, compared with $0.15 in Q1 2022.

First-Quarter Non-GAAP Measures

On a non-GAAP basis, Q1 2023 gross margin decreased 8% to $5.46 billion. Gross margin as a percent of revenue was 78.4%, an increase of 2.3 percentage points. The increase in gross margin percent was primarily driven by sales of COVID-19 antibodies in Q1 2022, partially offset by lower realized prices.

The effective tax rate on a non-GAAP basis was 12.8% in Q1 2023 compared with 10.3% in Q1 2022. The effective tax rate for Q1 2023 reflects the tax impact of the new Puerto Rico tax regime, partially offset by a net discrete tax benefit.

On a non-GAAP basis, Q1 2023 net income and EPS were $1.46 billion and $1.62, respectively, compared with $2.37 billion and $2.62 in Q1 2022. Non-GAAP EPS in Q1 2023 was inclusive of $0.10 of acquired IPR&D, compared with $0.15 in Q1 2022.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

First Quarter

2023

2022

% Change

Earnings per share (reported)

$ 1.49

$ 2.10

(29) %

Amortization of intangible assets

.11

.18

Net losses on investments in equity securities

.02

.34

Earnings per share (non-GAAP)

$ 1.62

$ 2.62

(38) %

Numbers may not add due to rounding.

Acquired IPR&D

.10

.15

(33) %

Selected Revenue Highlights

(Dollars in millions)

First Quarter

Selected Products

2023

2022

% Change

Trulicity

$ 1,977.1

$ 1,741.3

14 %

Verzenio

750.9

469.4

60 %

Jardiance(a)

577.5

419.4

38 %

Mounjaro

568.5

NM

Taltz

527.0

488.1

8 %

Humalog(b)

460.9

618.2

(25) %

Cyramza

236.8

230.3

3 %

Olumiant(c)

228.9

255.6

(10) %

Emgality

154.3

149.3

3 %

Tyvyt

61.0

85.5

(29) %

Alimta

58.2

343.9

(83) %

Retevmo

51.4

41.8

23 %

COVID-19 antibodies(d)

1,469.8

(100) %

Total Revenue

6,960.0

7,810.0

(11) %

(a) Jardiance includes Glyxambi, Synjardy and Trijardy XR

(b) Humalog includes Insulin Lispro

(c) Olumiant includes sales of baricitinib that were made pursuant to Emergency Use
Authorization (EUA) or similar regulatory authorizations

(d) COVID-19 antibodies include sales for bamlanivimab administered alone, for
bamlanivimab and etesevimab administered together, and for bebtelovimab, and were made
pursuant to EUAs or similar regulatory authorizations

NM – not meaningful

Trulicity

For Q1 2023, worldwide Trulicity revenue was $1.98 billion, an increase of 14% compared with Q1 2022. U.S. revenue increased 18% to $1.55 billion, driven by increased demand and, to a lesser extent, wholesaler buying patterns, partially offset by lower realized prices driven by higher contracted rebates as well as unfavorable segment mix. Lilly experienced intermittent delays in fulfilling certain U.S. Trulicity orders in Q4 2022. These delays persisted through Q1 2023, but at a reduced level. Revenue outside the U.S. was $429.7 million, an increase of 1%, driven by increased volume, largely offset by the unfavorable impact of foreign exchange rates and lower realized prices. Actions to manage strong demand across the company’s incretin portfolio, including measures to minimize existing patient impact in international markets, also affected volume.

Verzenio

For Q1 2023, worldwide Verzenio revenue increased 60% compared with Q1 2022 to $750.9 million. U.S. revenue was $461.1 million, an increase of 53%, driven by increased demand, partially offset by customer buying patterns. Revenue outside the U.S. was $289.8 million, an increase of 73%, driven by increased demand, partially offset by the unfavorable impact of foreign exchange rates and lower realized prices.

Jardiance

The company’s worldwide Jardiance revenue for Q1 2023 was $577.5 million, an increase of 38% compared with Q1 2022. U.S. revenue increased 43% to $329.4 million, primarily driven by increased demand. Revenue outside the U.S. was $248.1 million, an increase of 31%, primarily driven by increased volume, partially offset by the unfavorable impact of foreign exchange rates.

Jardiance is part of the company’s alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.

Mounjaro

For Q1 2023, worldwide Mounjaro revenue was $568.5 million. U.S. revenue was $536.4 million. Mounjaro launched in the U.S. for the treatment of type 2 diabetes in June 2022.

Taltz

For Q1 2023, worldwide Taltz revenue increased 8% compared with Q1 2022 to $527.0 million. U.S. revenue increased 2% to $312.2 million, driven by increased demand, largely offset by lower realized prices. Revenue outside the U.S. increased 19% to $214.8 million, driven by increased volume, partially offset by the unfavorable impact of foreign exchange rates.

Humalog

For Q1 2023, worldwide Humalog revenue decreased 25% compared with Q1 2022 to $460.9 million. U.S. revenue decreased 26% to $271.6 million, primarily driven by lower realized prices due to unfavorable segment mix. Revenue outside the U.S. decreased 24% to $189.3 million, primarily driven by lower realized prices due to the impact of VBP in China.

Olumiant

For Q1 2023, worldwide Olumiant revenue decreased 10% compared with Q1 2022 to $228.9 million. U.S. revenue decreased 41% to $42.3 million, driven by a decline in utilization for COVID-19 treatment, partially offset by increased utilization for the treatment of alopecia areata. Revenue outside the U.S. was $186.5 million, an increase of 1%, driven by increased volume, largely offset by a decline in utilization for COVID-19 treatment and the unfavorable impact of foreign exchange rates.

Emgality

For Q1 2023, Emgality generated worldwide revenue of $154.3 million, an increase of 3% compared with Q1 2022. U.S. revenue remained relatively flat as increased demand was offset by lower realized prices. Revenue outside the U.S. was $45.6 million, an increase of 11%, primarily driven by increased volume.

2023 Financial Guidance

The company has updated certain elements of its 2023 financial guidance on both a reported and non-GAAP basis. Since announcing financial guidance in December 2022, the U.S. dollar has weakened against most major currencies and full-year guidance has been updated based on recent spot rates. Our guidance does not include the potential impacts of the pending business development transactions associated with the sales of the company’s rights to both the olanzapine portfolio and Baqsimi.

Revenue guidance has been increased by $900 million to the range of $31.2 to $31.7 billion, driven by approximately $650 million associated with updates to foreign exchange rate assumptions, with the remainder attributable to underlying business performance.

Gross margin as a percent of revenue guidance remains unchanged on both a reported and non-GAAP basis at approximately 77% and 79%, respectively.

Marketing, selling and administrative expenses were increased by $100 million to reflect updated foreign exchange rate assumptions and are now expected to be in the range of $7.0 to $7.2 billion.

Research and development expenses were increased by $100 million driven by updated foreign exchange rate assumptions and progress within the late-stage portfolio, and are now expected to be in the range of $8.3 to $8.5 billion.

Acquired IPR&D of $105 million in Q1 2023 has also been incorporated into guidance.

Other income (expense) guidance remains unchanged at a range of ($200) to ($100) million of expense on both a reported and non-GAAP basis.

Based on these changes, EPS guidance has been increased to the range of $8.18 to $8.38 on a reported basis and $8.65 to $8.85 on a non-GAAP basis. The company’s 2023 financial guidance reflects adjustments shown in the reconciliation table below.

2023

Expectations

Earnings per share (reported)

$8.18 to $8.38

Amortization of intangible assets

.45

Net losses on investments in equity securities

.02

Earnings per share (non-GAAP)

$8.65 to $8.85

Numbers may not add due to rounding

The following table summarizes the company’s updated 2023 financial guidance:

2023 Guidance(1)

Prior

Updated

Revenue

$30.3 to $30.8 billion

$31.2 to $31.7 billion

Gross Margin % of Revenue (reported)

Approx. 77%

Unchanged

Gross Margin % of Revenue (non-GAAP)

Approx. 79%

Unchanged

Marketing, Selling & Administrative

$6.9 to $7.1 billion

$7.0 to $7.2 billion

Research & Development

$8.2 to $8.4 billion

$8.3 to $8.5 billion

Acquired IPR&D

n/a

$105 million(2)

Other Income/(Expense)

$(200) to $(100) million

Unchanged

Tax Rate

Approx. 13%

Unchanged

Earnings per Share (reported)

$7.90 to $8.10

$8.18 to $8.38

Earnings per Share (non-GAAP)

$8.35 to $8.55

$8.65 to $8.85

(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.

(2) Guidance does not include acquired IPR&D either incurred, or that may potentially be incurred, after Q1 2023.

Webcast of Conference Call

As previously announced, investors and the general public can access a live webcast of the Q1 2023 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 10 a.m. Eastern time today and will be available for replay via the website.

Curis to Release First Quarter 2023 Financial Results and Hold Conference Call on May 4, 2023

On April 27, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its first quarter 2023 financial results on Thursday, May 4, 2023, after the close of U.S. markets (Press release, Curis, APR 27, 2023, View Source,-2023 [SID1234630599]). Management will host a conference call on the same day at 4:30 p.m. ET.

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To access the live conference call, please dial (888)-346-6389 from the United States or (412)-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

Coherus and Junshi Biosciences Announce Toripalimab Studies to be Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 27, 2023 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that data presentations of four toripalimab pivotal clinical studies will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, which is being held from June 2-6, 2023 at McCormick Place in Chicago (Press release, Coherus Biosciences, APR 27, 2023, View Source [SID1234630598]).

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Presentations

Abstract #6009/Poster #1: "Final Overall Survival Analysis of JUPITER-02: a Phase 3 study of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)"
Principal Investigator: Prof. Rui-hua XU, Sun Yat-sen University Cancer Center
Poster Discussion Session: Head and Neck Cancer
Date: Monday, June 5, 2023, 4:30 p.m. Central Daylight Time

Abstract #9003: "Final overall survival and biomarker analyses of CHOICE-01: A double-blind randomized phase 3 study of toripalimab versus placebo in combination chemotherapy for advanced NSCLC without EGFR/ALK mutations"
Principal Investigator: Prof. Jie WANG, Cancer Hospital, Chinese Academy of Medical Sciences
Oral Abstract Session: Lung Cancer-Non-Small Cell Metastatic
Date and Time: Tuesday, June 6, 2023, 9:45 a.m. Central Daylight Time

Abstract #8501: "Perioperative toripalimab + platinum-doublet chemotherapy vs chemotherapy in resectable stage II/III non-small cell lung cancer (NSCLC): Interim event-free survival (EFS) analysis of the phase III NEOTORCH study"
Principal Investigator: Prof. Shun LU, Shanghai Chest Hospital
Oral Abstract Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Date and Time: Saturday, June 3, 2023, Session: 3:00-6:00 p.m., Presentation: 3:12 p.m. Central Daylight Time

Abstract #LBA1013: "TORCHLIGHT: a randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel (nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC)"
Principal Investigator: Prof. Zefei JIANG, Chinese PLA General Hospital
Rapid Abstract Session: Breast Cancer-Local/Regional/Adjuvant
Date and Time: Saturday, June 3, 2023, Session: 4:30-5:30 p.m., Presentation: 4:54 p.m. Central Daylight Time

The FDA has granted Breakthrough Therapy designations and priority review for the toripalimab Biologics License Application (BLA) for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system.

The FDA granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 and as monotherapy for patients with progression following platinum-based chemotherapy in the treatment of recurrent or metastatic NPC in 2020. The BLA for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are six approved indications for toripalimab in China:

unresectable or metastatic melanoma after failure of standard systemic therapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous NSCLC.
The first three indications have been included in the National Reimbursement Drug List ("NRDL") (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma.

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.