June 2021 – Page 162 – 1stOncology™: Cancer Intelligence Service

Calquence demonstrated fewer incidences of atrial fibrillation versus ibrutinib in previously treated patients with chronic lymphocytic leukaemia and sustained patient benefit at four years in the front-line setting

On June 7, 2021 AstraZeneca reported that Final results from the head-to-head ELEVATE-RR Phase III trial of Calquence (acalabrutinib) demonstrated non-inferior progression-free survival (PFS) and statistically significantly fewer events of atrial fibrillation versus ibrutinib in adults with previously treated chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults (Press release, AstraZeneca, JUN 7, 2021, View Source [SID1234583635]).1

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Separately, updated results at four years of follow up from the ELEVATE-TN Phase III trial continued to show a strong PFS benefit for Calquence as combination therapy or as monotherapy in previously untreated patients with CLL.

At a median follow up of 40.9 months, the ELEVATE-RR trial met its primary endpoint of PFS non-inferiority versus ibrutinib with a median PFS of 38.4 months in both arms (based on a hazard ratio [HR] of 1.0, 95% confidence interval [CI] 0.79-1.27). Patients treated with Calquence had a statistically significantly lower incidence of all-grade atrial fibrillation compared with patients treated with ibrutinib (9.4% versus 16.0%), a key secondary endpoint.2 Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.3

John C. Byrd, MD, Distinguished University Professor, The Ohio State University, and lead investigator of the ELEVATE-RR trial, said: "Cardiac adverse events are an important consideration for treating chronic lymphocytic leukaemia patients with Bruton’s tyrosine kinase inhibitors because they can produce significant morbidity in some cases and also lead patients to discontinue treatment. These data provide compelling evidence that acalabrutinib is a more tolerable option with reduced cardiovascular toxicity and overall fewer discontinuations due to adverse events, giving clinicians further reassurance when prescribing this medicine that patients can stay on treatment while maintaining ongoing control of their disease."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Tolerability is a critical factor in treating patients with chronic lymphocytic leukaemia who often remain on medicines for many years and experience multiple comorbidities. The totality of the Calquence data at ASCO (Free ASCO Whitepaper) confirm our confidence in the favourable benefit-risk profile of this medicine, with over 40 months of follow up in each of these two trials. Together, the results provide strong evidence that Calquence is a preferred option for people living with this chronic and devastating disease."

The results of both trials were presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on 7 June 2021.

ELEVATE-RR: Calquence versus ibrutinib in relapsed or refractory CLL
ELEVATE-RR (ACE-CL-006) is the first Phase III trial to compare two Bruton’s tyrosine kinase (BTK) inhibitors in patients with previously treated CLL with presence of 17p deletion or presence of 11q deletion.2 The trial met the non-inferiority endpoint for PFS defined by the trial for Calquence (n=268) versus ibrutinib (n=265) in patients with previously treated CLL with certain high-risk prognostic factors.2

Patients treated with Calquence had statistically significantly lower incidence of all-grade atrial fibrillation, a key secondary endpoint, compared with patients treated with ibrutinib (9.4% [n=25/266] versus 16.0% [n=42/263]; p=0.02).2

A lower frequency of adverse events (AEs) was observed with Calquence versus ibrutinib including lower common AEs, Grade 3 or higher AEs, serious AEs, treatment discontinuations due to AEs and overall cardiac events.2 The safety and tolerability of Calquence in ELEVATE-RR was consistent with the known profile of Calquence.

Adverse events led to treatment discontinuation in 14.7% of patients on Calquence and 21.3% of patients on ibrutinib. AEs of clinical interest for Calquence versus ibrutinib included cardiac events (all grade, 24.1%, and 30.0%, respectively), bleeding events (all grade, 38.0% and 51.3%, respectively), hypertension (all grade, 9.4% and 23.2%, respectively), infections (all grade, 78.2% and 81.4%, respectively), interstitial lung disease/pneumonitis (all grade, 2.6% and 6.5%, respectively) and second primary malignancies excluding non-melanoma skin cancer (all-grade, 9.0% and 7.6%, respectively).2 Serious AEs (any grade) occurred in 53.8% of patients on Calquence versus 58.6% of patients receiving ibrutinib.2

Median overall survival (OS) was not reached in either arm, with 63 (23.5%) patients in the Calquence arm, and 73 (27.5%) patients in the ibrutinib arm experiencing an event (HR of 0.82, 95% CI 0.59-1.15).2

ELEVATE-TN: Four-year follow up for Calquence in previously untreated CLL
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab or alone versus chlorambucil in combination with obinutuzumab in previously untreated patients with CLL.4 The trial met its primary endpoint (IRC-assessed PFS with Calquence plus obinutuzumab versus chlorambucil plus obinutuzumab) at the data cut-off for the interim analysis after a median follow up of 28.3 months.5

After a median follow up of 46.9 months, the ELEVATE-TN Phase III trial showed Calquence plus obinutuzumab reduced the risk of disease progression or death by 90% (HR 0.10, 95% CI 0.07-0.17) and as a monotherapy by 81% (HR 0.19, 95% CI 0.13-0.28) compared with chlorambucil plus obinutuzumab.4 Estimated PFS rates at 48 months for Calquence plus obinutuzumab or as monotherapy were 87% and 78%, respectively, versus 25% for chlorambucil plus obinutuzumab.4 PFS findings were consistent across high-risk subgroups.4 Median PFS was not yet reached for either Calquence arm at four years of follow up. Median OS was not reached in any treatment arm with a trend toward significance in the Calquence plus obinutuzumab group (p=0.0604).4

Summary of key efficacy results from the ELEVATE-TN trial4
Median follow up of 46.9 months (range: 0.0-59.4)

Efficacy measure

Calquence plus obinutuzumab

N=179

Calquence monotherapy

N=179

Chlorambucil plus obinutuzumab

N=177

PFS*: Overall population

Median (HR, 95% CI), months

(0.10; 0.07-0.17)

(0.19; 0.13-0.28)

27.8

p-value

<0.0001

–

Estimated PFS at 48 months, %

PFS*: Patients with del(17p) and/or mutated TP53

Median (HR, 95% CI), months

(0.17; 0.07-0.42)

(0.18; 0.07-0.46)

17.5

p-value

<0.0001

Estimated PFS at 48 months, %

ORR*

ORR, % (95% CI)

96.1

(92.1-98.1)

89.9

(84.7-93.5)

82.5

(76.2-87.4)

p-value

<0.0001

0.035

–

Median (HR, 95% CI), months

(0.50; 0.25-1.02)

(0.95; 0.52-1.74)

p-value

0.0604

0.9164

–

Estimated OS at 48 months, %

CI, confidence interval; NR, not reached; ORR, overall response rate; OS, overall survival
*Investigator-assessed.

The safety profile remained largely unchanged from the interim analysis at 24 months, with similar treatment discontinuation rates across arms (25.1%, 30.7% and 22.6% for Calquence plus obinutuzumab, Calquence monotherapy and chlorambucil plus obinutuzumab, respectively).4 The most common reasons for treatment discontinuation were AEs (12.8%, 12.34% and 14.7%, respectively) and progressive disease (4.5%, 7.8% and 1.7%, respectively).4

Selected AEs of interest of any grade in the Calquence combination arm (n=178), Calquence monotherapy arm (n=179) and chlorambucil plus obinutuzumab arm (n=169) included cardiac events (20.8%, 19.0% and 7.7%, respectively), bleeding (47.2%, 41.9% and 11.8%, respectively), hypertension (7.9%, 7.3% and 4.1%, respectively), infections (75.3%, 73.7% and 44.4%, respectively) and second primary malignancies (15.7%, 13.4% and 4.1%, respectively).4

CLL
Chronic lymphocytic leukaemia is the most common type of leukaemia in adults, with an estimated 114,000 new cases globally in 2017, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.1,6-8 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets. This could result in anaemia, infection and bleeding.6 B-cell receptor signalling through Bruton’s tyrosine kinase is one of the essential growth pathways for CLL.

ELEVATE-RR
ELEVATE-RR (ACE-CL-006) is a randomised, multicentre, open-label Phase III non-inferiority trial of Calquence versus ibrutinib in patients with relapsed or refractory CLL after at least one prior therapy, and at least one of the following prognostic factors: presence of 17p deletion, or presence of 11q deletion. In the trial, 533 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence (100mg orally twice daily) until disease progression or unacceptable toxicity. Patients in the second arm received ibrutinib (420mg orally once daily) until disease progression or unacceptable toxicity.2

The primary endpoint for the trial was PFS assessed by an independent review committee (non-inferiority; tested after 250 events, HR upper margin of <1.429).2 Secondary endpoints included incidence of atrial fibrillation, incidence of Grade 3 or higher infections, incidence of Richter’s transformation (a condition in which CLL changes into an aggressive form of lymphoma) and OS.2,9

ELEVATE-TN
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence alone or in combination with obinutuzumab versus chlorambucil in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression).4

The primary endpoint was PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint was IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints included objective response rate, time to next treatment, OS and investigator-assessed PFS.4 After interim analysis, assessments were by investigator only.4

Initial results from the ELEVATE-TN Phase III trial were presented in December 2019 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exhibition.10 The findings, along with previously reported data from the Phase III ASCEND trial in relapsed or refractory CLL, supported the approvals of Calquence by the US FDA and the Australian Therapeutic Goods Administration for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) and by the European Union and Health Canada for CLL.

Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.11,12 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.11

Calquence is approved for the treatment of CLL and SLL in the US, approved for CLL in the EU and several other countries worldwide, and approved in Japan for relapsed or refractory CLL and SLL. A Phase I trial is currently underway in Japan for the treatment of front-line CLL.

In the US and several other countries, Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The US MCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Calquence is not currently approved for the treatment of MCL in Europe or Japan.

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being evaluated for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenström’s macroglobulinaemia, follicular lymphoma and other haematologic malignancies.

AstraZeneca in haematology
AstraZeneca is pushing the boundaries of science to redefine care in haematology. Applying our deep understanding of blood cancers and leveraging our strength in solid tumour oncology, we are driving the development of novel therapies designed to target underlying drivers of disease across six scientific platforms. By addressing blood cancers with high unmet medical needs, our aim is to deliver innovative medicines and approaches to healthcare services that have a meaningful impact on patients and caregivers, transforming the haematologic cancer care experience.

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.

Article on CD40 agonistic antibodies published in Expert Opinion on Biological Therapy

On June 7, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the scientific journal Expert Opinion on Biological Therapy has published an article by scientists at Alligator Bioscience, reviewing the field of CD40 agonistic antibodies (Press release, Alligator Bioscience, JUN 7, 2021, View Source [SID1234583634]). The article provides an overview of the CD40 agonistic antibodies in clinical development and the current challenges and opportunities for this important class of immuno-oncology drugs.

Title: Rationale and clinical development of CD40 agonistic antibodies for cancer immunotherapy

Journal: Expert Opinion on Biological Therapy

Authors: Karin Enell Smith et al

"We’re very pleased to have this peer-reviewed article prepared by Alligator’s scientists published. It highlights the promising role of CD40 agonists in immuno-oncology and explains how Alligator’s CD40 agonist, mitazalimab, has best in class potential," said Søren Bregenholt, CEO of Alligator Bioscience. "We’re now looking forward to initiating the OPTIMIZE-1 Phase II study designed to assess the clinical efficacy of mitazalimab combined with chemotherapy in patients with metastatic pancreatic cancer."

Mitazalimab is an agonistic – or stimulatory – antibody that targets CD40, a receptor on dendritic cells, which are the cells that instruct T cells to kill cancer cells. Mitazalimab activates CD40 enabling dendritic cells to effectively stimulate the immune system directing T cells to selectively attack the tumor. This addresses one of the key mechanistic needs in immuno-oncology and highlights the potential of CD40 as a target to treat patients with metastatic cancer. Mitazalimab’s favorable efficacy-safety profile demonstrated in previous phase I studies, makes it ideal for combination with standard of care treatments such a chemotherapy, check-point inhibitors or cancer vaccines.

Autobahn Labs incubator announces partnership with Cold Spring Harbor Laboratory to advance novel science to the clinic

On June 6, 2021 Autobahn Labs, an early-stage drug discovery incubator, reported a new strategic venture collaboration with Cold Spring Harbor Laboratory (CSHL) (Press release, Evotec, JUN 6, 2021, View Source;announcements/press-releases/p/autobahn-labs-incubator-announces-partnership-with-cold-spring-harbor-laboratory-to-advance-novel-science-to-the-clinic-6068 [SID1234583737]). Together with Autobahn Labs, CSHL will identify promising research programs with therapeutic potential and partner to form promising new drug discovery companies.

"We’re delighted to partner with CSHL, expanding our reach and collaborations with top faculty working on truly compelling science with strong therapeutic potential," said Thomas Novak, PhD, Chief Scientific Officer of Autobahn Labs. "Cold Spring Harbor is a close-knit and collegial campus that also has cultivated one of the premier scientific meeting programs in the world."

"Autobahn has the ability to get involved early and put their resources into CSHL’s drug discovery programs and generate a pipeline of highly investable spin-out companies," said Andrew Whiteley, CSHL Vice President, Business Development and Technology Transfer. "This collaboration will enable us to more quickly advance our basic biology expertise from the lab to the clinic."

Under terms of the agreements with CSHL, Autobahn Labs will invest up to $5M in funding and biopharmaceutical services into specific programs yet to be identified. Since its launch in June 2020, Autobahn Labs has announced partnerships with four leading institutions and has started two new drug discovery programs.

Backed by Samsara BioCapital, Evotec SE, and KCK Ltd, Autobahn Labs invests earlier than traditional venture financing models, providing intellectual, financial and physical capital to efficiently and effectively advance new scientific discoveries from novel concept to preclinical drug candidate. Institutions benefit from Autobahn’s strategy and operational support, as well as the industry-leading drug discovery capabilities of Evotec, a global leader in drug discovery and development. Pre-agreement on many of the economic and intellectual property terms that govern the relationship further facilitates the negotiation and creation of jointly-owned new companies.

Innovent Releases the Phase Ia/Ib Dose-Escalation Trial Results of IBI110 (anti-LAG-3) in Patients with Advanced Solid Tumors at ASCO Annual Meeting 2021

The phase 1 study of IBI110 is a dose-escalation trial evaluating IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in patients with advanced solid tumors refractory to standard of care therapy. The study is comprised of Phase Ia, an IBI110 single-drug dose-escalation phase, and Phase Ib, the dose-escalation phase of IBI110 in combination with sintilimab (200mg). At disease progression, cross over from IBI110 monotherapy to combo (IBI110+ sintlilimab) was allowed at the investigators’ discretion. At data cutoff (February 9, 2021), 40 patients were enrolled and received treatment. 22 subjects were assigned in dose groups of 7 (0.01mg/kg~20mg/kg) in Phase Ia, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT) was observed. No adverse event (AE) led to discontinuation of IBI110 or sintilimab and no treatment-related death was reported. In terms of efficacy, a subject with advanced ovarian cancer who progressed on multiple prior systemic therapies achieved partial response after IBI110 monotherapy treatment and was still in the study for more than 6 months. 18 subjects were assigned in dose groups of 5 (0.3mg/kg~5mg/kg) in Phase Ib of IBI110 in combination with sintilimab, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT), adverse events leading to discontinuation or death was observed. At data cutoff (April 26, 2021), three subjects had achieved partial response with an objective response rate of 16.7% (3/18) in phase 1b, demonstrating a synergistic anti-tumor activity of IBI110 and sintilimab.

"The efficacy signal and safety profile we see with IBI110 in this study is exciting," said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics. "The single-drug efficacy demonstrated in the trial suggested a huge anti-tumor potential of this target. As we move ahead with the study, we look forward to greater clinical benefits of IBI110 in combination with sintilimab in patients in this trial. We are committed to innovation and relentless pursuit of breakthroughs for cancer patients. Aside from IBI110, we are also initiating phase 1 clinical trial on IBI323, a LAG-3/PD-L1 bispecific antibody, to fully investigate therapeutic value of LAG-3. "

Professor Caicun Zhou from Shanghai Pulmonary Hospital said: "IBI110’s good safety and preliminary efficacy data support the further exploration of this molecule in a variety of tumor types, including non-small cell lung cancer, small cell lung cancer, melanoma, etc. LAG-3 is the third validated immune-related target after PD-1 and CTLA-4. We look forward to seeing more positive results from the upcoming trials of IBI110."

About the Study

This study is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in advanced solid tumors. The study follows a classic 3+3 design. Patients received escalating doses of IBI110 once every 3 weeks in phase Ia and escalating doses of IBI110 in combination with TYVYT (sintilimab injection) 200 mg once every 3 weeks in phase Ib until disease progression, unacceptable toxicity, or withdrawal of consent.

Primary objectives of the trial were to evaluate the safety, tolerability and the antitumor activity of IBI110 monotherapy and in combination with sintilimab.

About LAG-3

Lymphocyte activation gene-3 (LAG-3) (CD223) is a novel 498-amino acid type I transmembrane protein identified on activated human NK and T-cell lines. LAG-3 (CD223) is a potential cancer immunotherapeutic target due to its negative regulatory role on T cells and its capacity, in combination with PD-1, to mediate a state of exhaustion.

About TYVYT (sintilimab Injection)

TYVYT (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Lilly. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, TYVYT (sintilimab Injection) has been approved for two indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
Additionally, Innovent currently has regulatory submissions under review in China for TYVYT (sintilimab Injection):

In combination with BYVASDA (bevacizumab injection) for the first-line treatment of hepatocellular carcinoma
The second-line treatment of squamous non-small cell lung cancer
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

TYVYT (sintilimab Injection) was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

Innovent and AnHeart Release Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting

On June 6, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with AnHeart Therapeutics Co., Ltd ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, reported a presentation of a scientific poster entitled "Preliminary results from TRUST: A phase II clinical study to investigate Taletrectinib in treating patients with ROS1 fusion positive non-small cell lung cancer (NSCLC)" which summarizes initial data from its ongoing trial of taletrectinib (NCT04395677) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Innovent Biologics, JUN 6, 2021, View Source [SID1234583621]).

As of the data cut-off date of April 8, 2021, there were 15 crizotinib treatment-naïve patients and 5 crizotinib pre-treated patients, who had been confirmed to be ROS1 fusion positive and assessed at least twice by investigators. The results were as follows:

In the crizotinib treatment-naïve patients (n=15), the overall response rate (ORR) was 93% (14/15) and the disease control rate (DCR) was 93% (14/15);
In the crizotinib pre-treated patients (n=5), the ORR was 60% (3/5); and the DCR was 100% (5/5). ROS1 G2032R resistant mutations were identified in three of the five patients and all three patients experienced tumor regressions; and
Taletrectinib has shown a manageable safety profile characterized primarily by gastrointestinal adverse events, with reversible increases of aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
"These safety and efficacy data for taletrectinib are very promising for ROS1 fusion positive lung cancer patients," said Dr. Caicun Zhou, director of the Department of Oncology, Shanghai Pulmonary Hospital. "Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, thus far all five patients continue to benefit from the drug."

"We are glad to see the study result of Taletrectinib can be presented at ASCO (Free ASCO Whitepaper) meeting, the most authoritative clinical oncology conference", said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, "In China, ROS1 positive fusion patients have limited treatment choices at present. More new drugs are needed to develop for clinical application. Taletrectinib has shown good efficacy and safety results, which offers hope to patients with ROS1 fusion positive non-small cell lung cancer."

"Our team is highly focused on completing patient enrollment for this phase II TRUST trial in Q3 2021," said Bing Yan, MD, co-founder and chief medical officer of AnHeart. "These data from the TRUST trial have built a solid foundation for our upcoming global trials of taletrectinib and will support us in seeking regulatory approvals of talectrectinib in China and globally. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to bringing taletrectinib to all ROS1 fusion positive patients in the near future upon approval."

About Taletrectinib

Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source

On 1 June 2021, Innovent and Anheart announced an exclusive license agreement for the co-development and commercialization of AnHeart’s lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK – in Greater China, including mainland China, Hong Kong, Macau and Taiwan.

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Month: June 2021

Calquence demonstrated fewer incidences of atrial fibrillation versus ibrutinib in previously treated patients with chronic lymphocytic leukaemia and sustained patient benefit at four years in the front-line setting

Article on CD40 agonistic antibodies published in Expert Opinion on Biological Therapy

Autobahn Labs incubator announces partnership with Cold Spring Harbor Laboratory to advance novel science to the clinic

Innovent Releases the Phase Ia/Ib Dose-Escalation Trial Results of IBI110 (anti-LAG-3) in Patients with Advanced Solid Tumors at ASCO Annual Meeting 2021

Innovent and AnHeart Release Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting