First-line Mitazalimab Plus Chemo Continues to Generate Responses in Metastatic PDAC
June 27th 2023Frontline treatment with the combination of the CD40-directed monoclonal antibody agonist mitazalimab and modified FOLFIRINOX continued to produce responses in patients with metastatic pancreatic ductal adenocarcinoma.
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Zanubrutinib Maintains PFS Benefit With Extended Follow-Up in Previously Untreated CLL/SLL
June 21st 2023Extended follow-up from the phase 3 SEQUOIA trial demonstrated that zanubrutinib maintained a progression-free survival benefit compared with bendamustine plus rituximab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Neoadjuvant treatment with pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab plus chemotherapy, then pembrolizumab monotherapy, led to a statistically significant improvement in pathological complete response rates vs neoadjuvant chemotherapy alone in patients with locally advanced, resectable gastric and gastroesophageal junction adenocarcinoma.
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FDA Accepts sNDA for Frontline NALIRIFOX in Metastatic Pancreatic Ductal Adenocarcinoma
June 14th 2023The FDA has accepted a supplemental new drug application seeking approval of the NALIRIFOX regimen comprised of irinotecan liposome injection plus 5-fluorouracil, leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma.
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Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML on Hold After Serious Grade 5 AE
June 14th 2023The phase 1 PLAT-08 trial investigating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia has been paused following the report of a grade 5 serious adverse effect.
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Brentuximab Vedotin Plus Nivolumab/Chemo Elicits 98% ORR in Early-Stage Classical Hodgkin Lymphoma
June 13th 2023Frontline treatment with the combination of brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine led to an overall response rate of 98% and a complete response rate of 93% in patients with early-stage, classical Hodgkin lymphoma.
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Cevidoplenib Elicits Platelet Responses in Persistent or Chronic Immune Thrombocytopenia
June 11th 2023The novel SYK inhibitor cevidoplenib dosed at 400 mg twice per day led to robust platelet responses in patients with persistent or chronic primary immune thrombocytopenia who did not respond or relapsed after at least 1 prior therapy.
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Ponatinib Plus Reduced-intensity Chemo Could Be New SOC in Newly Diagnosed Ph+ ALL
June 9th 2023Treatment with ponatinib plus reduced-intensity chemotherapy led to an improvement in minimal residual disease-negative complete remission rate compared with imatinib plus reduced-intensity chemotherapy in newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.
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Resection Should be Considered for Residual Non-Retroperitoneal Disease in Post-Chemo NSGCTs
June 8th 2023Although patients with metastatic nonseminomatous germ-cell tumors who had teratoma in the primary tumor were found to have a higher rate of teratoma in residual non-retroperitoneal disease following chemotherapy, those without teratoma in the primary tumor could have teratoma or active testicular germ-cell tumors in residual disease post-chemotherapy and should be considered for resection.
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Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy
June 7th 2023A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.
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Pembrolizumab Plus Chemo Does Not Significantly Improve Survival in TKI-resistant, EGFR+ NSCLC
June 6th 2023The addition of pembrolizumab to pemetrexed and platinum-based chemotherapy resulted in a numerical, but not statistically significant, improvement in progression-free survival or overall survival vs chemotherapy plus placebo in patients with TKI-resistant, EGFR-mutated, metastatic nonsquamous non–small cell lung cancer.
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Cilta-cel Possesses Potential to Be New SOC for Lenalidomide-refractory Myeloma After First Relapse
June 5th 2023Ciltacabtagene autoleucel significantly improved progression-free survival over standard-of-care pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone in patients with lenalidomide-refractory multiple myeloma who received 1 to 3 prior lines of therapy.
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Adjuvant Osimertinib Provides OS Benefit in EGFR+ Stage IB-IIIA NSCLC
June 4th 2023Treatment with adjuvant osimertinib produced a statistically significant and clinically meaningful improvement in overall survival compared with placebo in patients with resected, EGFR-mutated, stage IB to IIIA non–small cell lung cancer.
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Elranatamab Elicits Responses in Relapsed/Refractory Myeloma After Prior BCMA-directed Therapy
June 4th 2023Treatment with elranatamab monotherapy produced early, deep, and durable responses in patients with relapsed/refractory multiple myeloma who received a prior BCMA-directed therapy, according to a pooled analysis of the MagnetisMM-1, MagnetisMM-2, MagnetisMM-3, and MagnetisMM-9 trials.
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FDA Grants Priority Review to Lifileucel in Advanced Melanoma
May 30th 2023The FDA has granted priority review to the biologics license application for the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy.
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Durvalumab Plus Chemotherapy With or Without Olaparib Improves PFS in Advanced Endometrial Cancer
May 26th 2023The combination of durvalumab and platinum-based chemotherapy, followed by maintenance therapy with either durvalumab plus olaparib or durvalumab alone, elicited a statistically significant and clinically meaningful improvement in progression-free survival in patients with newly diagnosed, advanced or recurrent endometrial cancer.
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Pembrolizumab plus chemotherapy with or without bevacizumab led to a substantial improvement in overall survival vs placebo plus chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer, according to the final OS analysis of the KEYNOTE-826 trial.
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Sitravatinib Plus Nivolumab Fails to Meet OS End Point in Nonsquamous NSCLC
May 25th 2023The combination of sitravatinib and nivolumab did not meet the primary end point of overall survival compared with docetaxel as second- or third-line treatment for patients with advanced nonsquamous non–small cell lung cancer who progressed on prior chemotherapy and immune checkpoint inhibitor therapy.
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Voruciclib With or Without Venetoclax Shows Safety, Activity in R/R AML, B-cell Malignancies
May 24th 2023Voruciclib monotherapy and in combination with venetoclax demonstrated clinical activity and was well tolerated with no significant myelosuppression in heavily pretreated patients with relapsed/refractory acute myeloid leukemia or B-cell malignancies, according to initial data from a phase 1 trial.
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The National Institute for Health and Care Excellence has recommended the combination of pembrolizumab and lenvatinib for use in previously treated patients with advanced or recurrent endometrial cancer whose cancer has progressed on or after platinum-based chemotherapy and who cannot have curative surgery or radiotherapy.
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Milademetan Fails to Meet PFS End Point in Dedifferentiated Liposarcoma
May 22nd 2023Treatment with milademetan did not lead to a statistically significant improvement in progression-free survival compared with trabectedin in patients with dedifferentiated liposarcoma, failing to reach the primary end point of the phase 3 MANTRA trial.
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First-line Eftilagimod Alpha Plus Pembrolizumab Generates OS Benefit in PD-L1+ NSCLC
May 17th 2023Eftilagimod alpha plus pembrolizumab provided an overall survival benefit over what has been reported with historical controls when given as first-line treatment in patients with non–small cell lung cancer and a PD-L1 tumor proportion score of at least 1%.
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Osimertinib Plus Chemotherapy Improves PFS in EGFR+ Advanced NSCLC
May 17th 2023The combination of osimertinib and platinum-based chemotherapy led to a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib alone in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.
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