On January 18, 2022 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology company, developing new precision medicine treatment options for cancer patients in indications with the greatest unmet medical need including KRAS-mutated colorectal cancer, pancreatic cancer, and castrate-resistant prostate cancer, reported new data from its lead clinical program evaluating onvansertib in combination with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) (Press release, Cardiff Oncology, JAN 18, 2022, View Source [SID1234605525]). A subset of these data will be featured in a poster presented by Dr. Heinz-Josef Lenz, principal investigator, USC Norris Comprehensive Cancer Center, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCOGI) on Saturday, January 22, 2022.

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"As we have increased the number of patients evaluated and the duration of follow-up, our Phase 1b/2 trial has consistently generated data suggesting that onvansertib provides meaningful clinical benefits when added to SOC," said Katherine L. Ruffner, M.D., chief medical officer of Cardiff Oncology. "The objective response rate and median progression free survival observed substantially exceed what would be expected with SOC alone, and five patients receiving onvansertib have been able to pursue potentially curative metastasis-directed treatments. We also observed a confirmed complete response, which is exciting given the difficult-to-treat nature of second line mCRC patients."

The most current data for the trial are shown below and include patient follow up collected after the cutoff dates for both the ASCO (Free ASCO Whitepaper)-GI abstract and poster (one additional PR was recorded after December 3):

Efficacy data in evaluable patients (represents an update from ASCO (Free ASCO Whitepaper)-GI abstract/poster):
•Among patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) in combination with FOLFIRI-bev:
◦12 of 35 (34%) achieved an initial complete response (CR) or partial response (PR)
◦10 of 35 (29%) achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
◦33 of 35 (94%) had a best response of disease control (CR + PR + SD)
◦Objective response rates of 5-13% observed in historical control trials in similar patient populations treated with various different drug combinations, including the standard of care chemotherapy of FOLFIRI with bevacizumab1-4
•Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2)
◦17 of 48 (35%) achieved an initial CR or PR
◦13 of 48 (27%) have achieved a confirmed CR or PR (awaiting confirmatory scan for 1 patient)
◦44 of 48 (92%) had a best response of disease control (CR + PR + SD)
•Status of 4 unconfirmed PRs:
◦1 patient discontinued from the trial prior to confirmatory scan due to an adverse event that was unrelated to treatment (hepatitis B)
◦1 patient went from PR to SD at the confirmatory scan and patient subsequently discontinued from the trial to pursue potentially curative metastasis-directed therapy
◦1 patient went from PR to SD at the confirmatory scan (patient remains on treatment)
◦1 patient has yet to have their confirmatory scan
•5 of 48 (10%) evaluable patients discontinued therapy to pursue potentially curative metastasis- directed therapy (surgery or microwave ablation), including 2 patients with SD

Median progression free survival (mPFS; no update from ASCO (Free ASCO Whitepaper)-GI poster)
•mPFS has not yet been reached in patients treated per protocol at the RP2D
•mPFS across all response-evaluable patients (n = 48) is 9.4 months (95% confidence interval: 7.1 – not yet reached)
•mPFS of ~4.5-5.7 months has been reported in trials used as historical controls1-4

Biomarker data across all patients (no update from ASCO (Free ASCO Whitepaper)-GI poster):
•Responses (CRs or PRs) were observed across seven different KRAS mutation variants, including the 3 most commonly observed in colorectal cancer (G12D, G12V, G13D)
•Patients achieving a best response of a CR or PR showed the greatest decreases in plasma KRAS mutant allelic frequency (MAF) measured by droplet digital PCR (ddPCR) after 1 cycle (28 days) of therapy

Safety data across all patients (no update from ASCO (Free ASCO Whitepaper)-GI poster):
•The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 11% (84/788) of reported treatment-emergent adverse events (TEAEs) being G3/G4
◦The most commonly reported adverse event was neutropenia/neutrophil count decreased
◦Most reported TEAEs were manageable and reversible with supportive care

Baseline characteristics of patients at all dose levels (no update from ASCO (Free ASCO Whitepaper)-GI poster):

•The patients’ median age was 61 years (range 35-83), and 56% were male
•67% patients had previously received bevacizumab
•16 of 48 (33%) evaluable patients remain on trial at the data cutoff date

Mark Erlander, Ph.D., chief executive officer of Cardiff Oncology, commented, "These impressive results show radiographic responses across multiple KRAS mutation variants when onvansertib is combined with the standard of care regimen of FOLFIRI-bev and demonstrate a substantial increase in disease response relative to historical controls. We believe the data presented today further validate the potential of onvansertib to provide a meaningful improvement in the treatment outcome of a large patient population that has limited available treatment options. Looking forward, and with our strong cash position, we have the ability to explore the full potential of onvansertib."

Webcast and Conference Call
The newly announced data are being discussed today at 5:00 PM ET as part of a webcast and conference call with members of the Cardiff Oncology management team. To access the webcast, click here. To participate by phone, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13725845. Following the live event, an archived webcast will be available on the "Events" section of the Cardiff Oncology website.

About the Phase 1b/2 Trial of Onvansertib in the Second-Line Treatment of KRAS-mutated mCRC This is a multi-center, single-arm, Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second–Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, is enrolling patients with histologically confirmed metastatic and unresectable colorectal carcinoma harboring a KRAS mutation.
Patients must also have experienced disease progression or treatment intolerance to first-line treatment with fluoropyrimidine and oxaliplatin (FOLFOX or CapeOx) with or without bevacizumab to be eligible.
The trial is being conducted at the following cancer centers across the U.S.: USC Norris Comprehensive Cancer Center, The Mayo Clinic (Arizona, Rochester, and Jacksonville), Kansas University Medical Center (KUMC), CARTI Cancer Center and Inova Schar Cancer Institute. For more information on the trial, please visit NCT03829410.

References
1.Giessen et al., Acta Oncologica 2015, 54: 187-193
2.Cremolini et al., Lancet Oncol 2020, 21: 497–507
3.Antoniotti et al., Correspondence Lancet Oncol June 2020
4.Bennouna et al., Lancet Oncol 2013; 14: 29–37

On January 18, 2022 BioLineRx Ltd. (NASDAQ-CM: BLRX) (TASE: BLRX) a late clinical-stage biopharmaceutical company focused on oncology, reported that the Company has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding Motixafortide as a novel stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients (Press release, BioLineRx, JAN 18, 2022, View Source [SID1234605524]).

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The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA and, in particular, to confirm that the Company’s single Phase 3 pivotal study, GENESIS, is sufficient to support an NDA submission. During the pre-NDA meeting, the FDA agreed that the proposed data package is sufficient to support an NDA submission, which the Company continues to anticipate will occur in H1 2022.

"We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This successful meeting continues the positive momentum generated from the compelling results of our GENESIS Phase 3 study, which demonstrate a highly significant improvement over the current standard of care, alongside the positive results of the pharmacoeconomic study that we reported more recently. As a result, Motixafortide, if approved, has the potential to become the standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation, especially in light of new and more intense induction treatment regimens given to these patients, which make stem-cell mobilization more difficult than ever before," concluded Mr. Serlin.

In May 2021, BioLineRx announced positive top-line results from its GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). Importantly, ~90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session.

On January 18, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported the national launch of its new GeneStrat NGS genomic test, a blood-based tumor profiling test (Press release, Biodesix, JAN 18, 2022, View Source [SID1234605523]). The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.

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The GeneStrat NGS test is paired with advanced variant interpretation technology connected to a powerful knowledge database developed by PierianDx. Physicians will now receive a streamlined report, including genomic insights for more precise patient care in an unprecedented 72-hour turnaround time.

The GeneStrat NGS test is paid by Medicare under the National Coverage Determination (NCD) for NGS Manual 90.2 section D by Novitas Solutions.

The Company also announced the launch of its new IQLung Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state. The testing strategy also includes blood-based proteomic and genomic testing workflows for both early and advanced stage lung cancer that can aid physicians in making treatment decisions. Biodesix plans to add additional tests in development to their IQLung portfolio.

"Initiating treatment as early as possible can help improve patient outcomes," said Scott Hutton, CEO, Biodesix. "Studies show the length of time to receive tests results impacts how quickly a patient goes on treatment. Current NGS tests can take anywhere from a week to a month to return results. This delay of diagnostic information contributes to patient anxiety and compliance, further delaying treatment when time is imperative in fighting lung cancer. It is our mission to change this paradigm, and we offer tests that provide important results in three days so patients can begin treatment as swiftly as possible."

On January 18, 2022 Astrazeneca reported positive results from the HIMALAYA Phase III trial showed a single priming dose of tremelimumab added to Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment (Press release, AstraZeneca, JAN 18, 2022, View Source [SID1234605521]).

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This novel dose and schedule of Imfinzi and tremelimumab, an anti-CTLA4 antibody, is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab). Results from the trial will be presented on 21 January at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1,2 Approximately 80,000 people in the US, Europe and Japan and 260,000 people in China present with advanced, unresectable HCC each year.3 Only 7% of patients with advanced disease survive five years.4

Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA Phase III trial, said: "Patients with unresectable liver cancer face a dismal prognosis, and new treatment options are critical to improving long-term survival. The three-year overall survival rate and favourable safety profile seen with the STRIDE regimen set a new benchmark in this setting and underscore the potential of this innovative treatment approach."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The HIMALAYA trial reinforces our scientific approach for tremelimumab, tapping into the potential of CTLA-4 inhibition and a unique dosing regimen to prime the immune system to help patients live longer and with minimal side effects. We look forward to bringing potential new treatment options to patients with unresectable liver cancer, an area of high unmet need, as quickly as possible."

Patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 96.02% confidence interval [CI] 0.65-0.93; p=0.0035). Median OS was 16.4 months versus 13.8 for sorafenib. An estimated 31% of patients were still alive at three years versus 20% for sorafenib.

Results also showed an increase in objective response rate (ORR) with the STRIDE regimen versus sorafenib (20.1% vs. 5.1%). Median duration of response (DoR) was 22.3 months with the STRIDE regimen versus 18.4 with sorafenib. The addition of tremelimumab to Imfinzi did not increase severe liver toxicity, and no bleeding risk was observed.

HIMALAYA also tested Imfinzi monotherapy, which demonstrated non-inferior OS to sorafenib (HR 0.86; 95.67% CI 0.73-1.03; non-inferiority margin 1.08) with a median OS of 16.6 months versus 13.8, and an improved tolerability profile versus sorafenib.

Summary of efficacy resultsi:

STRIDE regimen

(n=393)

Imfinzi monotherapy (n=389)

Sorafenib

(n=389)

OSii,iii

Number of patients with event (%)

262 (67)

280 (72)

293 (75)

Median OS (95% CI) (in months)

16.4

16.6

13.8

Hazard ratio (96.02% CI)

p-value

0.78 (0.65, 0.93)

0.0035

OS rate at 24 months (%)

40.5

39.6

32.6

OS rate at 36 months (%)

30.7

24.7

20.2

ORR (%)

20.1

17.0

5.1

Median DoR (months)

22.3

16.8

18.4

i. Analysis was done at 71% maturity

ii. Investigator-assessed OS data cut-off date was 27 August 2021

iii. Median (range) follow-up durations at data cut-off: 33.18 (31.74-34.53), 32.56 (31.57-33.71) and 32.23 (30.42-33.71) months for STRIDE regimen, Imfinzi monotherapy and sorafenib, respectively.

The safety profiles of the STRIDE regimen and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified. Grade 3 or 4 treatment-related adverse events (AEs) were experienced by 25.8% of patients treated with the STRIDE regimen and by 12.9% of patients treated with Imfinzi alone, versus 36.9% of patients on sorafenib.

Incidence of Grade 3 or 4 treatment-related hepatic events were low across treatment arms (5.9% for the STRIDE regimen and 5.2% for Imfinzi, versus 4.5% for sorafenib). Treatment-related AEs led to treatment discontinuation in 8.2% of patients treated with the STRIDE regimen and 4.1% of patients treated with Imfinzi alone, versus 11% for sorafenib.

An additional presentation featured during the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium will showcase Imfinzi data from the TOPAZ-1 Phase III trial, demonstrating the potential of this medicine in the treatment of advanced biliary tract cancer.

Notes

Liver cancer

About 75% of all primary liver cancers are HCC.1 Between 80-90% of all patients with HCC also have cirrhosis, which is primarily caused by infection with the hepatitis B or C viruses.5 Chronic liver diseases are associated with inflammation that over time can lead to the development of HCC.5,6

More than half of HCC patients are diagnosed at advanced stages of the disease, often when symptoms first appear.7 A critical unmet need exists for patients with HCC who face limited treatment options.7 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the power of the immune system to treat HCC.7

HIMALAYA

HIMALAYA was a randomised, open-label, multicentre, global Phase III trial of Imfinzi monotherapy and the STRIDE regimen, comprising a single priming dose of tremelimumab 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.

The trial included a total of 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localised to the liver and surrounding tissue).

The trial was conducted in 190 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint was OS for STRIDE versus sorafenib and key secondary endpoints included OS for Imfinzi versus sorafenib, objective response rate and progression-free survival (PFS) for STRIDE and for Imfinzi alone.

Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.

Imfinzi is also approved for previously treated patients with advanced bladder cancer in several countries.

Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, small cell lung cancer (SCLC), bladder cancer, several gastrointestinal (GI) cancers, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumours.

Tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Tremelimumab is being tested in a clinical trial programme in combination with Imfinzi in NSCLC, SCLC, bladder cancer and liver cancer.

AstraZeneca in GI cancers

AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines spanning a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new diagnoses leading to approximately 3.6 million deaths.8

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.

Imfinzi (durvalumab) is being assessed in combinations including with tremelimumab in HCC, biliary tract, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings.

The Company aims to understand the potential of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in immunotherapy

Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome anti-tumour immune suppression.

AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and small, targeted molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On January 18, 2022 Alkermes plc (Nasdaq: ALKS) reported plans to present a poster related to nemvaleukin alfa (nemvaleukin), the company’s novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium, taking place Jan. 20-22, 2022 (Press release, Alkermes, JAN 18, 2022, View Source [SID1234605519]). The poster highlights clinical data related to advanced GI cancers from ARTISTRY-1, a phase 1/2 study evaluating the tolerability and efficacy of nemvaleukin administered intravenously as a monotherapy and in combination with pembrolizumab (KEYTRUDA), and preclinical data from the study of nemvaleukin in combination with novel agents in GI cancers.

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Details of the presentation are as follows:
Abstract: 659
Title: Nemvaleukin alfa combination therapy for gastrointestinal (GI) cancers: preclinical evidence and clinical data from the ARTISTRY-1 trial
Presenter: Ulka N. Vaishampayan, M.D., Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan
Presentation Date: The poster, along with a pre-recorded presentation, will be available on the ASCO (Free ASCO Whitepaper) GI virtual meeting platform beginning Jan. 20, 2022.

About Nemvaleukin Alfa ("nemvaleukin")
Nemvaleukin is an investigational, novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the Nemvaleukin Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Ongoing trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.