On October 28, 2022 AbbVie (NYSE:ABBV) reported that financial results for the third quarter ended September 30, 2022 (Press release, AbbVie, OCT 28, 2022, View Source [SID1234622576]).

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"We continue to see strong momentum from our key immunology assets, Skyrizi and Rinvoq, and this performance – combined with strength from other growth drivers within our diverse portfolio – has mitigated the impact of temporary economic headwinds on our aesthetics products to deliver another quarter of strong results," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Based upon our performance and confidence in AbbVie’s long-term outlook, we are once again meaningfully raising our dividend."

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.

Third-Quarter Results

Worldwide net revenues were $14.812 billion, an increase of 3.3 percent on a GAAP basis, or 5.4 percent on an operational basis.

Global net revenues from the immunology portfolio were $7.651 billion, an increase of 14.6 percent on a reported basis, or 16.4 percent on an operational basis.
Global Humira net revenues of $5.559 billion increased 2.5 percent on a reported basis, or 3.9 percent on an operational basis. U.S. Humira net revenues were $4.956 billion, an increase of 7.4 percent. Internationally, Humira net revenues were $603 million, a decrease of 25.9 percent on a reported basis, or 16.8 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $1.397 billion, an increase of 75.4 percent on a reported basis, or 78.3 percent on an operational basis.
Global Rinvoq net revenues were $695 million, an increase of 53.5 percent on a reported basis, or 59.3 percent on an operational basis.
Global net revenues from the hematologic oncology portfolio were $1.650 billion, a decrease of 11.7 percent on a reported basis, or 9.9 percent on an operational basis.
Global Imbruvica net revenues were $1.135 billion, a decrease of 17.4 percent, with U.S. net revenues of $849 million and international profit sharing of $286 million.
Global Venclexta net revenues were $515 million, an increase of 4.5 percent on a reported basis, or 11.3 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.672 billion, an increase of 6.7 percent on a reported basis, or 8.3 percent on an operational basis.
Global Botox Therapeutic net revenues were $699 million, an increase of 8.2 percent on a reported basis, or 10.0 percent on an operational basis.
Vraylar net revenues were $554 million, an increase of 20.2 percent.
Global Ubrelvy net revenues were $160 million.
Global net revenues from the aesthetics portfolio were $1.301 billion, an increase of 4.0 percent on a reported basis, or 8.1 percent on an operational basis.
Global Botox Cosmetic net revenues were $637 million, an increase of 16.9 percent on a reported basis, or 21.6 percent on an operational basis.
Global Juvederm net revenues were $352 million, a decrease of 0.6 percent on a reported basis, or an increase of 5.3 percent on an operational basis.
On a GAAP basis, the gross margin ratio in the third quarter was 66.1 percent. The adjusted gross margin ratio was 85.4 percent.
On a GAAP basis, selling, general and administrative (SG&A) expense was 22.3 percent of net revenues. The adjusted SG&A expense was 20.9 percent of net revenues.
On a GAAP basis, research and development (R&D) expense was 10.9 percent of net revenues. The adjusted R&D expense was 10.8 percent of net revenues.
Acquired IPR&D and milestones expense was 0.3 percent of net revenues.
On a GAAP basis, the operating margin in the third quarter was 31.1 percent. The adjusted operating margin was 53.4 percent.
Net interest expense was $497 million.
On a GAAP basis, the tax rate in the quarter was 10.2 percent. The adjusted tax rate was 12.9 percent.
Diluted EPS in the third quarter was $2.21 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.66. These results include an unfavorable impact of $0.02 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. The approval is supported by data from the SELECT-AXIS 2 clinical trial, in which Rinvoq delivered rapid and meaningful disease control as well as significant improvement in signs and symptoms of nr-axSpA. This approval marks the sixth FDA approved indication for Rinvoq in chronic immune-mediated diseases.
AbbVie announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The positive opinion is based on results from three Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. If the CHMP recommendation is accepted by the European Commission (EC), this would mark the third indication for Skyrizi in the European Union. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
At the United European Gastroenterology (UEG) Week 2022, AbbVie shared 17 abstracts, including seven oral presentations, from a broad range of studies in inflammatory bowel disease (IBD). Highlights included final analyses from the U-ACHIEVE Phase 3 maintenance study of Rinvoq in moderately to severely active ulcerative colitis (UC), data from the U-EXCEL Phase 3 study evaluating the efficacy and safety of Rinvoq as induction therapy for use in adults with moderately to severely active CD as well as data evaluating Skyrizi for use in patients with moderate to severe CD.
At the American College of Gastroenterology (ACG) Annual Scientific Meeting, AbbVie presented 26 abstracts that illustrate AbbVie’s commitment to providing research and innovative solutions that support patients with high disease burden and unmet need. Key presentations focused on the treatment of moderate to severe CD, including late-breaking Phase 3 data from the Rinvoq 52 week maintenance trial, as well as efficacy and safety outcomes from the Skyrizi pivotal clinical program.
At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie presented 23 abstracts from across its dermatology portfolio that underscore AbbVie’s commitment to advancing research in dermatology for people living with immune-mediated skin diseases such as psoriasis (PsO), psoriatic arthritis (PsA), atopic dermatitis (AD) and vitiligo. Presentations included long-term efficacy and safety results, including real-world data, from studies of Skyrizi in moderate to severe PsO and active PsA as well as data from the largest-of-its-kind study that demonstrate the real-world burden of AD.
AbbVie announced that the FDA approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. The approval marks the first approved treatment option for children with cGVHD under 12 years of age and the only Bruton’s tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.
At the International Parkinson and Movement Disorder Society’s (MDS) International Congress, AbbVie presented 13 abstracts across multiple disease states that highlighted AbbVie’s continued commitment to advancing the management of movement disorders. Highlights included results from the Phase 3 M15-736 trial evaluating the continuous subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in people with advanced Parkinson’s disease (PD) as well as data on the real-world efficacy of Botox (onabotulinumtoxinA) for the treatment of spasticity and treatment of cervical dystonia.
At the Migraine Trust International Symposium (MTIS), AbbVie shared 13 abstracts, including 4 oral presentations, from a wide range of studies across its migraine portfolio that underscore AbbVie’s leadership and commitment to people living with migraine. Highlights included Phase 3 PROGRESS study results evaluating Qulipta (atogepant) for the preventive treatment of chronic migraine as well as data from studies evaluating Botox and Ubrelvy (ubrogepant) in the treatment of migraine.
Allergan Aesthetics announced that the FDA approved Juvederm Volux XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. Juvederm Volux XC is the first and only hyaluronic acid (HA) filler to receive FDA approval for jawline definition.
At the American Society for Dermatologic Surgery (ASDS), Allergan Aesthetics shared data from across its facial injectables, body contouring and skincare portfolio that highlighted Allergan Aesthetics’ continued commitment to advancing aesthetic medicine. Highlights included analyses of 15 years of post-marketing surveillance data that demonstrated the global reported rate of delayed-onset nodules associated with dermal fillers on the Vycross technology platform is low, as well as results from three clinical studies showcasing a customizable platform with patent-pending LTN Complex, to address the appearance of facial hyperpigmentation.
AbbVie announced the acquisition of DJS Antibodies (DJS), a biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins. The acquisition includes DJS’ lead program DJS-002, a potential first-in-class LPAR1 antagonist antibody in preclinical studies for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases as well as the company’s proprietary HEPTAD platform.
Full-Year 2022 Outlook

AbbVie is confirming the midpoint of its full-year 2022 adjusted diluted EPS guidance range and narrowing the range from $13.76 – $13.96 to $13.84 – $13.88, which includes an unfavorable impact of $0.25 per share related to acquired IPR&D and milestones expense incurred year-to-date through the third quarter 2022. The company’s 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the third quarter of 2022, as both cannot be reliably forecasted.

Company Declares Dividend Increase of 5.0 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.41 per share to $1.48 per share beginning with the dividend payable on February 15, 2023 to shareholders of record as of January 13, 2023. This reflects an increase of approximately 5.0 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the company’s inception in 2013, AbbVie has increased its quarterly dividend by 270 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On October 28, 2022 ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the third quarter ended September 30, 2022, and provided an update on recent corporate activities (Press release, ASLAN Pharmaceuticals, OCT 28, 2022, View Source [SID1234622575]).

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"In the third quarter we presented a number of new and important insights on eblasakimab’s differentiated mechanism of action in neuronal itch and inflammatory pathways, and the potential improvements for AD patients related to itch and sleep loss, which are often the most burdensome symptoms reported by these patients," shared Dr Carl Firth, CEO, ASLAN Pharmaceuticals. "We look forward to the topline readout of Phase 2b data evaluating eblasakimab in biologic naïve moderate-to-severe AD patients in Q2 2023. In the lead up to the new data that we will generate from both TREK-AD and TREK-DX, we are building a robust set of insights from ongoing research collaborations that will be presented early next year, to support eblasakimab’s potential as a differentiated treatment for moderate-to-severe AD with broad therapeutic potential in Type 2-driven inflammatory diseases."

Third quarter 2022 and recent business highlights

Eblasakimab

In August, the Company signed a licensing agreement with Belle.ai for the use of belleStudy digital image capture software across several global sites in the ongoing TREK-AD study of eblasakimab in AD. The easy-to-use solution enables standardized recording of AD disease severity scores through image capture and the technology will allow ASLAN to further enhance its quality control procedures in the TREK-AD study.
In September, three posters with new data on biomarkers, efficacy measures and patient reported outcome measures from the previously reported Phase 1b proof-of-concept trial of eblasakimab were presented at the 31st European Academy of Dermatology and Venereology (EADV) annual congress. The data showed eblasakimab suppresses downstream inflammatory biomarkers of AD, and this effect continues four to six weeks after the last dose administered. Patients treated with eblasakimab demonstrated notable improvements in quality-of-sleep measures and eblasakimab was shown to reduce P-NRS (itch) scores versus placebo, with improvements throughout the eight-week course of treatment across all dose cohorts. The posters can be found in the News and Publications section of the Company’s website.
In September, the Company commenced TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD patients), a new clinical trial studying eblasakimab in dupilumab-experienced moderate-to-severe AD patients. The trial consists of a 16-week treatment period and a 12-week safety follow-up period. The primary efficacy endpoint is percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. In combination with the data from biologic naïve AD patients in the TREK-AD trial, we believe the results from the TREK-DX study in the biologic-experienced population could position eblasakimab as a preferred first choice treatment for moderate-to-severe AD.
The Company hosted a Research and Development Day in September where management gave a comprehensive update on the eblasakimab development program. Dr Peter A Lio, from Northwestern University Feinberg School of Medicine, and Dr Shawn Kwatra, from Johns Hopkins University, discussed the emerging unmet needs, therapeutic landscape and underlying molecular mechanisms in AD and Type 2-driven diseases. A replay of the event and presentation materials can be found in the Investor Relations section of the Company’s website.
In September, the Company presented new translational data on eblasakimab at the late-breaker session of the European Society for Dermatological Research (ESDR) annual meeting. The first data from the ongoing collaboration with Dr Shawn Kwatra and Dr Madan Kwatra showed increased IL-13Rα1 expression on mast cells and eosinophils in skin samples from AD patients, reinforcing the central role of IL-13Rα1 in AD. In human neuron models, eblasakimab significantly reduced neuronal itch sensitization caused by distinct IL-4 and IL-13 itch pathways and an emerging role of IL-13Rα1 signaling in mediating neuronal excitability and sensitivity beyond AD was also identified.
Farudodstat (ASLAN003)

A clinical development plan in skin autoimmune diseases is being finalized and a Phase 2 trial is expected to commence in the first half of 2023.
Anticipated upcoming milestones

First patient enrolled in the TREK-DX trial by the end of 2022.
New translational data highlighting the unique effects of eblasakimab’s mechanism of action will be presented in early 2023.
Topline data from the Phase 2b TREK-AD trial of eblasakimab is expected in Q2 2023.
Third quarter 2022 financial highlights

Cash used in operating activities for the third quarter of 2022 was US$9.1 million compared to US$7.6 million in the same period in 2021.
Cash, cash equivalents and short-term investments as of September 30, 2022, were US$68.9 million.
Research and development expenses were US$8.0 million in the third quarter of 2022 compared to US$5.3 million in the third quarter of 2021. The increase was due to clinical development and manufacturing costs for eblasakimab.
General and administrative expenses were US$2.3 million in the third quarter of 2022 compared to US$2.8 million in the third quarter of 2021.
Net loss attributable to stockholders for the third quarter of 2022 was US$10.9 million compared to a net loss of US$8.6 million for the third quarter of 2021.
The weighted average number of American Depositary Shares (ADS) outstanding in the computation of basic loss per share for the third quarter of 2022 was 69.7 million (representing 348.7 million ordinary shares), the same as the third quarter of 2021. One ADS is the equivalent of five ordinary shares.

On October 28, 2022 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the initial data from the Phase 1 dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors (Press release, Nuvalent, OCT 28, 2022, View Source [SID1234622574]). These data will be presented today in the "New Drugs on the Horizon" oral plenary session at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium in Barcelona, Spain.

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NVL-520 is a novel brain-penetrant ROS1-selective inhibitor created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, off-target central nervous system (CNS) adverse events, and brain metastases that may limit the use of currently available ROS1 tyrosine kinase inhibitors (TKIs).

"Currently approved and investigational ROS1 TKIs are important treatment options for advanced ROS1 fusion-positive cancers. However, these drugs can have key limitations. These include the inability to treat on-target resistance and brain metastases effectively, and an association with neurologic adverse events," said Alexander Drilon, M.D., Chief, Early Drug Development Service, Memorial Sloan Kettering Cancer Center (MSK) and presenting investigator. "These preliminary data support NVL-520 as a potential best-in-class ROS1-selective inhibitor that may combine, for the first time, potent and selective targeting of diverse ROS1 fusions and secondary ROS1 resistance mutations including G2032R, brain penetrance, and the avoidance of TRK inhibition that can be dose limiting."

As of September 1, 2022, 35 subjects have been enrolled in the Phase 1 portion of the ARROS-1 trial. Treatment with NVL-520 across five evaluated dose levels ranging from 25 mg once daily (QD) to 125 mg QD resulted in exposures above all target efficacy thresholds. As of the preliminary data cut-off date of September 13, 2022, no dose-limiting toxicities (DLTs), treatment-related serious adverse events (SAEs), treatment-emergent dizziness, or adverse events leading to treatment reductions or discontinuations were observed.

Preliminary activity data reported as of the data cut-off date were available from 21 heavily pre-treated response-evaluable NSCLC patients, of which partial responses were observed in 48% (10/21). To evaluate key target characteristics of NVL-520, activity was examined in subgroups including:

Patients with ROS1 G2032R mutations (Objective Response Rate (ORR) 78%, 7/9);

Patients with a history of CNS metastases (ORR 73%, 8/11);

The most heavily pre-treated of patients, receiving two or more prior ROS1 TKIs and one or more prior lines of chemotherapy (ORR 53%, 9/17); and

Patients previously treated with lorlatinib or repotrectinib (ORR 50%, 9/18).

As of the preliminary data cut-off date, 76% (16/21) of response-evaluable patients continued on NVL-520 treatment. Enrollment in the Phase 1 portion of the trial is ongoing.

"We are excited to present the first look at the safety and clinical activity of NVL-520 from our ARROS-1 clinical trial, which we believe supports NVL-520 as a potential best-in-class ROS1-selective inhibitor that may be capable of overcoming the limitations of current approved and investigational ROS1 TKIs," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "Across all evaluated dose levels, NVL-520 exhibited activity in a heavily pre-treated patient population, many of whom have exhausted all available treatment options and would have been excluded from other investigational ROS1 TKI studies. Importantly, the favorable safety profile and lack of dose reductions or discontinuations due to adverse events reflected in this preliminary data suggest that NVL-520 has the potential to provide deep and durable responses and may be able to move up in the treatment paradigm for patients with ROS1-driven cancers."

"We believe today’s preliminary results further support Nuvalent’s approach of applying innovative chemistry and structure-based drug design to well-defined target product profiles focused on addressing medical needs that have been identified in collaboration with leading physician-scientists," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "Not only has this approach rapidly delivered the encouraging preliminary results for NVL-520 presented today, it underpins our work

across our entire pipeline, including parallel lead candidate NVL-655 for ALK-positive NSCLC, and our recently announced development candidate for HER2ex20-driven cancers, NVL-330. I congratulate the entire Nuvalent team for their dedication and tireless efforts, and offer sincere gratitude to the patients, caregivers and investigators who are participating in the ARROS-1 trial."

NVL-520 First-In-Human Preliminary Phase 1 Data

NVL-520 is currently being evaluated in the ongoing ARROS-1 Phase 1/2 clinical trial, a first-in-human study of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors. The Phase 1 dose escalation portion is enrolling ROS1-positive NSCLC patients who have previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who have been previously treated. The Phase 1 portion of the trial is designed to evaluate the overall safety and tolerability of NVL-520, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity.

As of September 1, 2022, 35 subjects were enrolled in the Phase 1 portion of the ARROS-1 trial, of which 34 patients had ROS1-positive NSCLC and 51% (18/35) had a history of CNS metastases.

The patient population was heavily pre-treated:

77% (27/35) had received three or more prior lines of anti-cancer therapy;

71% (25/35) had received two or more prior ROS1 TKIs and one or more lines of chemotherapy; and

80% (28/35) had received a ROS1 TKI other than crizotinib or entrectinib, including lorlatinib (57%, 20/35) or repotrectinib (34%, 12/35).

Preliminary Safety and Pharmacokinetic Analysis

Preliminary safety and pharmacokinetics of NVL-520 were evaluated as of the data cut-off date of September 13, 2022. Patients were treated in five dose cohorts of 25 mg, 50 mg, 75 mg, 100 mg, or 125 mg once daily NVL-520.

NVL-520 demonstrated exposure above all target efficacy thresholds (ROS1 wild type and ROS1 G2032R in both the periphery and in the CNS). Favorable pharmacokinetics and low intra-cohort patient PK variability were observed, with exposure increasing with increasing dose level and half-life supportive of once daily dosing.

A favorable preliminary safety profile was observed with NVL-520 treatment in the 35 patients enrolled across the dose-escalation portion of ARROS-1, suggesting the potential for a highly ROS1-selective, TRK sparing design. There were no DLTs, no treatment-related SAEs, no treatment related dizziness, and no adverse events leading to dose reduction or discontinuation of NVL-520 through the preliminary data cut-off date.

Most treatment-related adverse events (TRAEs) were low-grade and manageable, and the favorable preliminary safety profile allowed for achievement of exposure levels well above target thresholds for both ROS1 and ROS1 resistance variants in both the CNS and the periphery. To date, a maximum tolerated dose has not been reached and Phase 1 is ongoing

to determine the RP2D.

Preliminary Activity Analysis

As of the preliminary data cut-off date of September 13, 2022, 21 patients with NSCLC were response-evaluable by investigator assessment with duration of treatment ranging from one to more than eight months.

Key findings include early anti-tumor activity in ROS1-positive NSCLC patients, including objective responses (RECIST 1.1) in:

Heavily pre-treated patients: Partial Responses (PRs) were observed in 48% (10/21) of all response-evaluable patients, with 76% (16/21) continuing on treatment. Responses were observed in 53% (9/17) of patients who received two or more prior TKIs and one or more prior lines of chemotherapy, in 50% (9/18) of patients previously treated with lorlatinib or repotrectinib, and across all dose levels evaluated.

Patients with ROS1 G2032R resistance mutation: Of nine patients with known ROS1 G2032R resistance mutation, responses were observed in 78% (7/9) including in two of three patients previously treated with repotrectinib, and tumor shrinkage was observed in 100% (9/9). Notably, complete clearance of G2032R allele was observed in all seven patients with G2032R detected on central ctDNA analysis.

Patients with CNS metastases: Intracranial PRs were observed in 100% (3/3) patients with measurable (>10 mm) CNS metastases. Responses were observed in 73% (8/11) of patients with a history of CNS metastases, and no CNS progression was observed in any of the 35 treated patients.

Combined with the favorable tolerability observed across the dose levels evaluated through the preliminary data cut-off date, these data also suggest that NVL-520 is a potential best-in-class therapy that may be able to move up the treatment paradigm for patients with ROS1-positive NSCLC.

The ARROS-1 clinical trial is continuing to enroll patients in the Phase 1 portion of the trial and is focused on further characterizing the safety profile of NVL-520, its pharmacokinetic profile, and determining the RP2D.

Once a safe and tolerable dose is determined as the RP2D, the trial is designed to transition directly into the Phase 2 portion, which will evaluate the overall activity of NVL-520 in several expansion cohorts of patients defined based on the number and type of prior anti-cancer therapies they have received. The Phase 2 cohorts are designed to support potential registration in patients with ROS1-positive NSCLC who are kinase inhibitor-naïve and in those who have been previously treated with ROS1 kinase inhibitors.

Webcast and Conference Call Information

Nuvalent will host a live webcast and conference call today at 8:30am EDT to discuss these results. The event is accessible through the "Events" section of the Investors page of www.nuvalent.com or by dialing (866) 652-5200 (domestic) or (412) 317-6060 (international) and referring to conference ID 10171503. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

About NVL-520

NVL-520 is a novel brain-penetrant ROS1-selective inhibitor designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with the prevalent G2032R resistance mutation and those with the S1986Y/F, L2026M, or D2033N resistance mutations. NVL-520 has been designed for brain penetrance to potentially improve treatment options for patients with brain metastases. NVL-520 has been observed in preclinical studies to selectively inhibit wild-type ROS1 and its resistance variants over the structurally related tropomyosin receptor kinase (TRK) family to potentially avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and drive more durable responses for patients. NVL-520 is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

On October 28, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported that it will release financial and operational results for third quarter 2022 on Thursday, November 3, 2022, before markets open (Press release, Aurinia Pharmaceuticals, OCT 28, 2022, View Source [SID1234622573]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update.

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Interested participants can dial 877-407-9170 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On October 28, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the outcome of the meeting of the U.S. Food and Drug Administration ("FDA") Oncologic Drugs Advisory Committee ("ODAC"), which reviewed investigational 131I-omburtamab ("omburtamab") for the treatment of CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, OCT 28, 2022, View Source [SID1234622572]). The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.

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"We are disappointed by the outcome of today’s meeting, as patients with CNS/leptomeningeal metastasis from neuroblastoma are in need of effective and safe treatment options," said Thomas Gad, President, and Interim Chief Executive Officer. "Y-mAbs is committed to working closely with the FDA on their review of the Biologic License Application ("BLA") for omburtamab ahead of their decision. We want to thank all of the patients, caregivers, and healthcare providers who participated in the studies of this life-threatening condition."

ODAC reviewed data from omburtamab’s clinical development program with a focus on study 03-133 (a pivotal phase 1 study) and study 101 (a pivotal phase 2 study) as well as the historical control group.

Y-mAbs BLA submission for omburtamab was accepted for Priority Review by the FDA on May 31, 2022, with a Prescription Drug User Fee Act ("PDUFA") target date of November 30, 2022. The FDA is not bound by the Advisory Committee’s recommendations but generally takes the recommendation into consideration when making its decision.

Researchers at MSK developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.