Excerpt:GAVRETO is a kinase inhibitor indicated for treatment of:...Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
Title:
RET targeted therapies Retevmo, Gavreto to compete in Korea
Excerpt:On Tuesday, the MFDS approved Roche’s Gavreto to treat adult patients with RET fusion-positive locally advanced or metastatic NSCLC and adult patients with RET-mutated locally advanced or metastatic medullary thyroid cancer requiring systemic therapy....The permits for the two therapies were based on their response rates and duration of response in phase 1/2 trials.
Title:
European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Excerpt:Roche...announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto® (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
Title:
CStone Announces New Drug Approval of GAVRETO (pralsetinib) as First Selective RET Inhibitor in China, Providing a New Therapy for a Subset of Non-Small Cell Lung Cancer Patients
Excerpt:CStone Pharmaceuticals...announces that the National Medical Products Administration (NMPA) of China has approved GAVRETO (pralsetinib) capsules for the treatment of adult patients with locally advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) after platinum-based chemotherapy.
Evidence Level:Sensitive: B - Late Trials
Title:
Pralsetinib in patients with RET fusion-positive non-small cell lung cancer: A plain language summary of the ARROW study
Excerpt:Overall, the ARROW study showed that pralsetinib was effective in shrinking tumours in patients with RET fusion+ NSCLC regardless of previous treatment history.
DOI:10.2217/fon-2023-0155
Evidence Level:Sensitive: B - Late Trials
Title:
CStone Pharmaceuticals Announces China’s NMPA has Accepted its New Drug Application with Priority Review Designation for Pralsetinib for the Treatment of Patients with RET Fusion-Positive NSCLC
Excerpt:We are pleased to see that the NMPA has accepted the company’s NDA for pralsetinib with the priority review designation for the treatment of RET fusion-positive NSCLC patients previously treated with platinum-based chemotherapy.
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC
Excerpt:...- Must have a diagnosis of locally advanced (non-resectable) or metastatic RET-fusion positive NSCLC...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Phase 1 Study of the Highly-Selective RET Inhibitor, BLU 667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
Excerpt:...Diagnosis during dose expansion (Part 2) – All patients (with the exception of Groups 3, 4 and 9) must have an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below. ...
More C2 evidence
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
Excerpt:...Pathologically documented and definitively diagnosed non-resectable or metastatic NSCLC with a RET fusion for patients who are either treatment naïve, or who have been previously treated with systemic therapy....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
Excerpt:...- participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy....
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A study of BLU-667 in patients with lung cancer, and thyroid cancer, and other solid tumors
Excerpt:...Diagnosis during dose expansion (Phase 2) – All patients (with the exception of patients with MTC enrolled in Groups 3, 4 and 9) must have an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local testing of tumor or circulating tumor nucleic acid in blood; as detailed below. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A study of BLU-667 in patients with lung cancer
Excerpt:...Patient must meet 1 of the following 2 criteria: a. Have a documented RET fusion using either tissue or plasma as determined by a local test. ...
Evidence Level:Sensitive: C2 – Inclusion Criteria
Title:
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Excerpt:...- Participant must have a documented RET-fusion...
Less C2 evidence
Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer
Excerpt:Pralsetinib showed robust and durable clinical activity with a well-tolerated safety profile in Chinese patients with RET fusion-positive NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
Title:
37P - Pralsetinib in acquired RET fusion positive advanced non-small cell lung cancer patients after resistance to EGFR/ALK-TKI: a China multi-center, real-world data(RWD) analysis
Excerpt:This multicenter, retrospective, real-world data analysis enrolled thirty-one aNSCLC with acquired RET-fusion…Patients who received pralsetinib-based therapy had a longer PFS and TTF compared with patients in cohort 2 (PFS: 8.42 months vs. 6.97 months, TTF: 6.48 months vs. 4.24 months).
Evidence Level:Sensitive: C3 – Early Trials
Title:
389P - Updated efficacy and safety of pralsetinib in Chinese patients with advanced RET fusion+ non-small cell lung cancer
Excerpt:With longer follow-up, pralsetinib continues to demonstrate deep and durable response and long-term clinical benefit in RET fusion+ NSCLC Chinese patients with or without prior platinum-based chemotherapy.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pralsetinib in RET fusion-positive non-small-cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP)
Excerpt:62 patients with RET-fusion positive NSCLC received pralsetinib at 20 Italian centers….The objective response rate (ORR) was 66 % [95 % confidence interval (CI), 53-81] in the evaluable population (n = 59). The disease control rate (DCR) was 79 %. After a median follow-up of 10.1 months, the median progression free survival was 8.9 months (95 %CI, 4.7-NA)....In the real-world setting, pralsetinib confirmed durable systemic activity and intracranial response in RET-fusion positive NSCLC.
DOI:10.1016/j.lungcan.2022.11.005
Evidence Level:Sensitive: C3 – Early Trials
Title:
1124P - Pralsetinib in RET fusion-positive non-small cell lung cancer: A real-world data (RWD) analysis from the Italian expanded access program (EAP)
Excerpt:A retrospective efficacy and safety analysis was performed on data from patients with RET fusion positive NSCLC who were enrolled in the pralsetinib Italian expanded access program (EAP)….The objective response rate (ORR) was 66% [95% confidence interval (CI), 53–81] in the evaluable population (n=58). The disease control rate (DCR) was 79%. After a median follow-up of 10.1 months, the median progression free survival was 8.9 months (95% CI, 4.7–NA). In patients with measurable brain metastases (n = 6) intracranial ORR was 83%, and intracranial DCR was 100%....In the real-world setting, pralsetinib confirmed durable systemic activity and intracranial response in RET fusion-positive NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
Title:
1170P - Updated efficacy and safety data from the phase I/II ARROW study of pralsetinib in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC)
Excerpt:...281 pts with RET fusion+ NSCLC had received pralsetinib...The ORR was 63.1% in pts with prior platinum treatment and 77.6% in those who were systemic treatment-naïve (Table), consistent with earlier data cuts. Median overall survival was 44.3 months in pre-treated pts and not reached in treatment-naïve pts.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and efficacy of pralsetinib in RET fusion-positive non-small-cell lung cancer including as first-line therapy: update from the ARROW trial
Excerpt:Between 17 March 2017 and 06 November 2020 (data cutoff), 281 patients with RET fusion–positive NSCLC were enrolled. The ORR was 72% (54/75; 95% CI, 60–82) for treatment-naïve patients and 59% (80/136; 95% CI, 50–67) for patients with prior platinum-based chemotherapy (enrolment cutoff for efficacy analysis: 22 May 2020)....Pralsetinib treatment produced robust efficacy and was generally well tolerated in treatment-naïve patients with advanced RET fusion–positive NSCLC.
DOI:10.1016/j.annonc.2022.08.002
Evidence Level:Sensitive: C3 – Early Trials
Title:
Extrapulmonary tuberculosis in patients with RET fusion-positive non-small cell lung cancer treated with pralsetinib: A Korean single-centre compassionate use experience
Excerpt:From April 2020, we administered pralsetinib to a total of 10 patients with RET fusion-positive non-small cell lung cancer...Of the nine patients with measurable lesions, seven achieved a partial response. Additionally, one patient without measurable lesions also showed a clinical response.
DOI:https://doi.org/10.1016/j.ejca.2021.09.037
Evidence Level:Sensitive: C3 – Early Trials
Title:
Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
Excerpt:Roche...today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor....The CHMP recommendation is based on the results of the phase I/II ARROW study, in which Gavreto demonstrated rapid, potent, and durable clinical activity in patients with advanced RET fusion-positive NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Efficacy and Safety of Pralsetinib in Chinese Patients with Advanced RET Fusion+ Non-Small Cell Lung Cancer
Excerpt:Pralsetinib shows high ORRs in Chinese RET fusion+ NSCLC patients regardless of prior therapy….Pralsetinib safety profile in Chinese patients is manageable, with no new safety signals detected. Overall, pralsetinib showed a favorable benefit-risk profile, offering a transformative medicine to Chinese RET-fusion driven advanced NSCLC patients.
Evidence Level:Sensitive: C3 – Early Trials
Title:
MA02.02 - Efficacy and Safety of Pralsetinib in Chinese Patients with Advanced RET Fusion+ Non-Small Cell Lung Cancer
Excerpt:RET fusion+ Chinese NSCLC patients without or with prior platinum-based chemotherapy were enrolled and administered with pralsetinib...Pralsetinib shows high ORRs in Chinese RET fusion+ NSCLC patients regardless of prior therapy....Pralsetinib is a promising targeted therapy with rapid and deep clinical activity in RET fusion+ NSCLC Chinese patients regardless of prior therapies.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study
Excerpt:Of 233 patients with RET fusion-positive NSCLC...Overall responses were recorded in 53...of 87 patients with previous platinum-based chemotherapy, including five (6%) patients with a complete response; and 19...of 27 treatment-naive patients, including three (11%) with a complete response....Pralsetinib is a new, well-tolerated, promising, once-daily oral treatment option for patients with RET fusion-positive NSCLC.
DOI:https://doi.org/10.1016/S1470-2045(21)00247-3
Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and efficacy of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer: Update from the ARROW trial.
Excerpt:ARROW is a phase 1/2 open-label study conducted at 84 sites in 13 countries. Phase 2 expansion cohorts included patients with RET fusion–positive NSCLC….Pralsetinib showed rapid, potent, and durable clinical activity in patients with RET fusion-positive NSCLC (regardless of prior therapies), including poor prognosis patients not eligible for platinum-based therapy.
DOI:10.1200/JCO.2021.39.15_suppl.9089
Evidence Level:Sensitive: C3 – Early Trials
Title:
JICC01.14 - Efficacy and Safety of Pralsetinib in Chinese Patients with Advanced RET Fusion+ Non-Small Cell Lung Cancer after Platinum-Based Chemotherapy
Excerpt:This is the first pivotal study to show that pralsetinib has deep and durable antitumor activity, and is well-tolerated in a cohort of Chinese patients with RET fusion+ NSCLC previously treated with platinum-based chemotherapy.
Evidence Level:Sensitive: C3 – Early Trials
Title:
CStone Pharmaceuticals Announced that the Registrational Study of Pralsetinib in Chinese RET-Fusion NSCLC Patients Achieved the Expected Results, Supporting Plans to Submit an NDA to the NMPA for Pralsetinib in the Near Future
Excerpt:Overall, the data showed that efficacy and safety outcomes in Chinese patients with RET-fusion NSCLC were consistent with previously reported data from the global patient population in the ARROW trial.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Registrational dataset from the phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC).
Excerpt:54 pts with advanced solid tumors had received pralsetinib at starting dose of 400 mg QD with median follow-up 8.8 months. ORR, disease control rate (DCR), and % of pts with tumor size reduction are shown in the table for pts with metastatic RET fusion+ NSCLC.
DOI:10.1200/JCO.2020.38.15_suppl.9515
Evidence Level:Sensitive: C3 – Early Trials
Title:
Registrational dataset from the phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC).
Excerpt:...354 pts with advanced solid tumors had received pralsetinib at starting dose of 400 mg QD with median follow-up 8.8 months….ORR was similar regardless of RET fusion partner, prior therapies, or central nervous system involvement. Overall there were 7 (6%) complete responses, 4 (5%) in prior platinum pts and 3 (12%) in treatment naïve pts; median time to response overall was 1.8 months and median duration of response (DOR) was not reached (95% CI, 11.3–NR)....data demonstrate that pralsetinib has rapid, potent, and durable clinical activity in pts with advanced RET fusion+ NSCLC regardless of RET fusion genotype...
DOI:10.1200/JCO.2020.38.15_suppl.9515
Evidence Level:Sensitive: C3 – Early Trials
Title:
Blueprint Medicines Announces Top-line Data for Pralsetinib and Initiates Rolling NDA Submission to FDA for the Treatment of Patients with RET Fusion-Positive Non-Small Cell Lung Cancer
Excerpt:As the clinical data for pralsetinib have matured, with deep and durable responses along with robust evidence of activity against brain metastases, our confidence has continued to grow in the potential of pralsetinib to provide lasting benefit to a broad population of patients with RET fusion-positive NSCLC...
Evidence Level:Sensitive: C4 – Case Studies
Title:
Case report: Recurrent lung infections following treatment with pralsetinib for an elderly patient with RET-fusion positive NSCLC
Excerpt:Our study demonstrates that pralsetinib is an effective therapeutic option that provides survival benefits for elderly NSCLC patients harboring RET fusion.
DOI:https://doi.org/10.3389/fonc.2022.1024365
Evidence Level:Sensitive: C4 – Case Studies
Title:
Real-world outcomes of immune checkpoint inhibitors and selective RET inhibitors for RET fusion non-small cell lung cancer
Excerpt:One patient acquiring RET fusion after EGFR-TKI resistance received pralsetinib monotherapy and obtained clinic response...Selective RET inhibitors showed durable efficacy compared with cabozantinib for RET fusion NSCLC.