Exploring treatment options in cancer: tumor treatment strategies

Pembrolizumab By Merck For Non-Hodgkin Lymphoma: Likelihood Of Approval

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Tevimbra By BeiGene For Follicular Lymphoma: Likelihood Of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tevimbra overview

Tislelizumab (Baizean, Tevimbra, Tizveni) is a humanized monoclonal antibody that belongs to a class of immuno-oncology agents. It is formulated as concentrated solution for infusion for intravenous route of administration. Baizean is used for the treatment of patients with classical Hodgkin's lymphoma (cHL) who have received at least two prior therapies and treatment for patients with locally advanced or metastatic urothelial carcinoma (UC). It is also indicated as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Baizean is indicated for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, including patients with advanced colorectal cancer (CRC) who had been treated with fluoropyrimidine, oxaliplatin and irinotecan and other advanced solid tumors who develop disease progression after prior treatment and have no satisfactory alternative treatment options. Baizean is indicated as a treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression or are intolerant to first-line standard chemotherapy. Tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). It is also indicated to treat cancers associated with homologous-recombination deficient (HRD).

Tislelizumab is under development for the treatment of locally advanced rectal cancer, hepatocellular carcinoma (HCC), glioblastoma multiforme (GBM), acute myelocytic leukemia, relapsed and refractory acute myeloid leukemia, primary mediastinal large B-cell lymphoma, triple negative breast cancer (TNBC), gallbladder cancer, pancreatic ductal adenocarcinoma, recurrent head and neck cancer squamous cell carcinoma, locally advanced or metastatic urothelial carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, metastatic esophageal, HER2 positive breast cancer, gastric, or gastroesophageal junction carcinoma (as a first line therapy), squamous non-small cell lung cancer, advanced solid tumors such as triple negative breast cancer, ovarian cancer, colorectal cancer, cervical cancer, pancreatic cancer, gastric cancer, hepatocellular carcinoma, non-squamous non-small cell lung cancer, sarcomas, cholangiocarcinoma, chronic lymphocytic leukemia (CLL), follicular lymphoma, aggressive lymphoma, including diffuse large B-cell lymphoma (DLBCL), renal cell carcinoma, squamous cell carcinoma, cutaneous squamous cell carcinoma, adrenocortical carcinoma, metastatic esophageal squamous cell carcinoma, urothelial carcinoma, mesothelioma, adenocarcinoma of mandible, undifferentiated adenocarcinoma from teratoma, blood borne cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, small-cell lung cancer,  metastatic adenocarcinoma of the pancreas, non-small cell lung cancer, T-cell lymphomas such as anaplastic T-cell lymphoma, Extranodal NK/T-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), relapsed or refractory classical Hodgkin lymphoma (cHL), gastrointestinal stromal tumor (GIST), mantle cell lymphoma, marginal zone B cell lymphoma, adenoid cystic carcinoma, nasopharyngeal cancer, renal pelvis cancer, ureter cancer, bladder cancer, nasopharyngeal cancer, oral cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, thymic carcinoma or urethral cancer. It is administered by intravenous drip route and subcutaneous route. The drug candidate is a highly selective and potent, humanized anti-PD-1 monoclonal antibody.

It was also under treatment for the treatment of duodenal cancer, anal squamous cell cancer, glioblastoma multiforme, non-muscle invasive bladder cancer (MIBC), Waldenstrom macroglobulinemia, ESCC, NSCLC,  high-risk myelodysplastic syndromes, adenocarcinoma of the gastroesophageal junction, RHNSCC, esophageal cancer ,TNBC, sezary syndrome, mycosis fungoides, GIST, HCC, angioimmunoblastic T-cell lymphoma (AITL)/immunoblastic lymphadenopathy, peripheral T-cell lymphomas (PTCL), natural killer cell lymphomas, anaplastic large cell lymphoma (ALCL), endometrial cancer, fallopian tube cancer, head and neck cancer squamous cell carcinoma, merkel cell carcinoma, metastatic adenocarcinoma of the pancreas, brain metastasis, metastatic castration-resistant prostate cancer (mCRPC), muscle invasive bladder cancer (MIBC), ovarian cancer, pancreatic cancer, peritoneal cancer, renal cell carcinoma, sarcomas, small-cell lung cancer, squamous cell carcinoma, thyroid cancer.

BeiGene overview

BeiGene is a biotechnology company. It specializes in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers Zanubrutinib, a small molecule inhibitor to treat various blood cancers and Sonrotoclax, a small molecule Bcl-2 inhibitor for treating chronic lymphocytic leukemia. BeiGene also provides Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. The company has operations in the US, Australia, Germany, Spain, Canada, Switzerland and Italy. BeiGene is headquartered in the Cayman Islands.

For a complete picture of Tevimbra's drug-specific PTSR and LoA scores, buy the report here.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData's Pharmaceutical Intelligence Center.

Real-World Data May Confirm Monjuvi's Efficacy In Large B-Cell Lymphoma

The real-world effectiveness of Monjuvi for relapsed or refractory diffuse large B-cell lymphoma in the U.S. Was demonstrated, according to data from a retrospective analysis.

Real-world data from the U.S. Confirms the effectiveness of Monjuvi for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The real-world effectiveness of Monjuvi (tafasitamab-cxix) in U.S. Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) was confirmed, along with factors associated with survival, according to data from a retrospective medical chart review presented at the 2024 ASH Annual Meeting.

At a median follow-up time of 14.7 months from Monjuvi initiation, the real-world progression-free survival (PFS) with Monjuvi was 11.3 months in the overall population (181 patients), and the real-world overall survival (OS) was 24.8 months. The real-world overall response rate (ORR) to the agent was 73.5%, which comprised a complete response (CR) rate of 23.2% and a partial response (PR) rate of 50.3%. In the patients who achieved a real-world CR or PR with the agent (133 patients), the real-world duration of response (DOR) was 9.6 months.

An analysis showed that factors significantly linked with increased risk of progression included receiving the agent in the third to fifth line (51 patients) versus the second line (130 patients), having Ann Arbor stage 3 to 4 disease (169 patients) versus stage 1 to 2 (10 patients), increasing Charlson Comorbidity Index scores (181 patients) and bulky (36 patients) versus non-bulky (145 patients) disease.

Moreover, factors significantly associated with increased risk of mortality included receiving Monjuvi in the third to fifth line versus the second line, increasing age, ECOG performance status of 2 or higher versus below 2 and bulky versus non-bulky disease.

Glossary:

Progression-free survival (PFS): time without disease worsening.

Overall survival (OS): time until death from any cause.

Overall response rate (ORR): percentage of patients with tumor reduction.

Complete response (CR): no detectable cancer.

Partial response (PR): tumor reduction, but not complete.

Duration of response (DOR): time response lasts.

Stable disease (SD): cancer neither grows nor shrinks.

Ann Arbor stage: system to classify lymphoma spread.

Charlson Comorbidity Index scores: predicts mortality based on comorbidities.

Bulky disease: large tumor mass.

Non-bulky disease: small or no large tumor mass.

ECOG performance status: measures a patient's ability to perform daily activities, with scores from 0 (fully active) to 5 (dead). Higher scores indicate greater impairment.

"The additional follow-up from the initial data collection allowed for a more robust evaluation of the real-world effectiveness of [Monjuvi] in patients with relapsed or refractory DLBCL, predominantly in the community practice setting," lead study author Dr. Kim Saverno of Incyte Corporation, in Wilmington, Delaware, said in a poster presentation of the data. "These results support a real-world clinical benefit for [Monjuvi], with the greatest benefit observed when [the agent] was received in second versus later lines of therapy."

Additional treatment outcome data showed that in those who received Monjuvi in the second line (130 patients), the real-world ORR was 78.5%; this was comprised of a CR rate of 27.7% and a PR rate of 50.8%. For this group, the stable disease (SD) rate was 8.5%, the progressive disease (PD) rate was also 8.5%, and 4.6% of patients did not have these data available. In the group of patients who received the immunotherapy in the third line (43 patients), the real-world ORR was 62.8%; this comprised a CR rate of 11.6% and a PR rate of 51.2%. In this subset, the SD and PD rates were 18.6% and 11.6%, respectively; 7% of patients did not have these data available.

In patients who experienced a real-world CR as a best response to Monjuvi (42 patients), the median real-world DOR was 19.2 months. In those who achieved a real-world PR as a best response to the agent (91 patients), the median real-world DOR was 8.5 months.

The CD19-targeted immunotherapy Monjuvi was approved by the FDA in July 2020 for use in combination with Revlimid (lenalidomide) in adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma and who are not candidates to undergo autologous stem cell transplant. To date, few studies have evaluated the agent in a US real-world setting, according to Saverno. She added that data from a real-world study were previously shared, but had a limited follow-up time of 6.5 months, which "precluded robust evaluations of the clinical effectiveness" of the agent.

For patients to be considered eligible for the analysis, they must have started treatment with Monjuvi with or without concomitant Revlimid for relapsed or refractory disease on or following Oct. 21, 2020; be at least 18 years old at the time treatment with the agent was started; and have undergone at least four months of follow-up since treatment started. Those who died during this four-month interval were still permitted. If patients received the agent as part of an interventional clinical trial, they were excluded.

A total of 181 patients were included in the study; 144 of these patients were still alive at last follow-up of initial data collection which had occurred between Feb. 22, 2023, and March 29, 2023. Of those patients, 137 patients had additional follow-up data available and underwent additional data collection between Dec. 18, 2023, and Jan. 31, 2024. A total of 106 patients were alive at last follow-up.

"Over 70% of patients received [Monjuvi] in the second line, and 71% of patients had discontinued [Monjuvi] at the last follow-up, mostly due to disease progression," Saverno noted. "Over half of the patients were still alive at the last follow-up, and among the patients still alive, half [were] still receiving [Monjuvi] at the time of the most recent follow-up."

In the 181 total patients, the median age at the time of Monjuvi initiation was 71.1 years. Most patients were White (64.1%), and more than half of patients were male (56.4%). Regarding Ann Arbor stage at time of treatment initiation, 5.5% had stage 1 or 2 disease, 93.4% had stage 3 or 4 disease; this information was unknown for 1.1% of patients. ECOG performance status at the time of treatment initiation was 0 to 1 for 52.5% of patients and 2 or higher for 47.5% of patients. Revised International Prognostic Index for Diffuse Large B-cell Lymphoma was 3 to 5 for 80.5% of patients and 1 to 2 for 19.5% of patients.

"This study is impacted by limitations inherent to real-world studies, such as unobserved and missing data," Saverno concluded. "The number of participating oncologists was small and thus may not reflect the treatment patterns of all US oncologists managing patients with DLBCL."

Reference:

"Real-world effectiveness of tafasitamab (tafa) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in the United States." By Dr. Kim Saverno et al, Blood.

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