Associate Editorial Director, OncLive®
Kristi Rosa joined MJH Life Sciences in 2016 and has since held several positions within the company. She helped launch the rapidly growing infectious disease news resource Contagion, strengthened the Rare Disease Report, of HCPLive, and now oversees OncLive and its flagship publication OncologyLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com
177Lu-PNT2002 Significantly Improves rPFS Vs ARPI in Metastatic Castration-Resistant Prostate Cancer
December 20th 2023Treatment with 177Lu-PNT2002 resulted in a significant improvement in radiographic progression-free survival vs abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer whose disease had progressed on an androgen receptor pathway inhibitor.
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Dostarlimab Plus Chemo Followed by Dostarlimab/Niraparib Improves PFS in Endometrial Cancer
December 20th 2023Dostarlimab plus carboplatin and paclitaxel, followed by maintenance dostarlimab and niraparib, significantly improved PFS vs placebo plus chemotherapy followed by placebo in patients with primary advanced or recurrent endometrial cancer, according to data from the phase 3 RUBY trial.
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Acalabrutinib Triplet Shows Early Signals of Activity, Safety in R/R Mantle Cell Lymphoma
December 19th 2023The combination regimen comprised of acalabrutinib, venetoclax, and obinutuzumab proved to be safe and feasible and to elicit responses in patients with high-risk, relapsed or refractory mantle cell lymphoma.
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TP-3654 Demonstrates Favorable Tolerability, Early Clinical Activity in R/R Myelofibrosis
December 19th 2023The oral selective PIM1 kinase inhibitor TP-3654 appeared to be well tolerated and to show early signals of spleen volume reduction, symptom improvement, and correlating cytokine reductions in patients with relapsed or refractory myelofibrosis, according to preliminary data.
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FDA Issues Complete Response Letter to Cosibelimab for Cutaneous Squamous Cell Carcinoma
December 18th 2023The FDA has issued a complete response letter to the biologic license application seeking the approval of cosibelimab for use in patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation.
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OBX-115 Elicits Responses in Advanced or Metastatic Melanoma
December 16th 2023The tumor-infiltrating lymphocyte cell therapy OBX-115 produced responses with no dose-limiting toxicities in heavily pretreated patients with advanced or metastatic melanoma whose who had progressed on anti–PD-1 and anti–CTLA-4 therapy with disease that was primary-resistant to immune checkpoint inhibitor therapy.
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FDA Grants Fast Track Status to Naporafenib Plus Trametinib for Advanced NRAS-Mutated Melanoma
December 15th 2023The FDA has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.
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RP1 Plus Cemiplimab Misses Response End Points in Locally Advanced or Metastatic CSCC
December 14th 2023The combination of RP1 and cemiplimab provided a numerical, but not statistically significant, improvement in response rates vs cemiplimab alone in patients with locally advanced or metastatic cutaneous squamous cell carcinoma, missing the primary end points of the phase 2 CERPASS trial.
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Dostarlimab Plus Chemo Granted EU Approval for dMMR/MSI-H Endometrial Cancer
December 14th 2023The European Commission has granted marketing authorization to dostarlimab paired with carboplatin and paclitaxel in adults with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are eligible to receive systemic treatment.
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Axatilimab Elicits Responses With Manageable Safety in Recurrent/Refractory cGVHD
December 11th 2023Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.
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Pirtobrutinib Demonstrates Durable Efficacy in Covalent BTK Inhibitor–Pretreated CLL/SLL
December 10th 2023Pirtobrutinib continued to showcase clinically meaningful efficacy in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who had prior exposure to a covalent BTK inhibitor.
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Atezolizumab Plus Neoadjuvant HP/Chemo Does Not Significantly Improve pCR in HER2+ Breast Cancer
December 8th 2023The addition of atezolizumab to neoadjuvant trastuzumab plus pertuzumab (HP) and chemotherapy led to a numerical, but not statistically significant, increase in pathologic complete response vs HP/chemotherapy alone in patients with HER2-positive operable breast cancer.
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Inavolisib Plus Palbociclib and Fulvestrant Improves PFS in PIK3CA-Mutated HR+ Breast Cancer
December 7th 2023The addition of inavolisib to palbociclib and fulvestrant improved progression-free survival vs palbociclib and fulvestrant alone in select patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative, locally advanced or metastatic breast cancer.
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Neoadjuvant Pembrolizumab Plus Chemo Improves pCR Across Key ER+ Breast Cancer Subgroups
December 6th 2023The addition of pembrolizumab to neoadjuvant chemotherapy followed by adjuvant pembrolizumab plus endocrine therapy improved pathologic complete responses in key subsets of patients with early-stage, high-risk, estrogen receptor–positive/HER2-negative breast cancer enrolled in the phase 3 KEYNOTE-756 trial.
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FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer
December 5th 2023The FDA has granted priority review to the supplemental biologics license application seeking the conversion of the accelerated approval of mirvetuximab soravtansine-gynx in patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who previously received 1 to 3 lines of systemic treatment to full approval.
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Sintilimab Triplet Demonstrates Efficacy With Acceptable Safety in pMMR/MSS CRC
November 30th 2023The triplet combination of sintilimab, chidamide, and bevacizumab resulted in a high 18-week progression-free survival rate with a favorable toxicity profile in patients with microsatellite stable or mismatch repair–proficient metastatic colorectal cancer, according to data from the phase 2 CAPability-01 trial.
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First-Line Pembrolizumab Demonstrates Durable Clinical Benefit in MSI-H/dMMR mCRC
November 30th 2023Pembrolizumab continued to demonstrate at trend toward improved overall survival compared with chemotherapy in patients with microsatellite instability–high or mismatch repair–deficient metastatic colorectal cancer.
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Camrelizumab Plus Famitinib Shows Promise in Recurrent or Metastatic Cervical Cancer
November 29th 2023The combination comprised of camrelizumab and famitinib showcased improved efficacy with a manageable safety profile vs camrelizumab monotherapy or investigator’s choice of chemotherapy in patients with recurrent or metastatic cervical cancer.
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Nimotuzumab With Concurrent Chemoradiotherapy Shows Activity in Cervical Squamous Cell Carcinoma
November 28th 2023Nimotuzumab given concurrently with chemoradiotherapy demonstrated efficacy and favorable tolerability in patients with locally advanced cervical squamous cell carcinoma, according to data from a randomized, controlled, open-label, multicenter study.
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Retifanlimab Continues to Elicit Responses in Recurrent MSI-H or dMMR Endometrial Cancer
November 28th 2023Retifanlimab-dlwr continued to elicit responses with acceptable tolerability in patients with recurrent microsatellite instability–high or mismatch–repair deficient endometrial cancer, according to final findings from cohort H of the phase 1 POD1UM-101 trial.
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Belantamab Mafodotin Plus Bortezomib/Dexamethasone Improves PFS in R/R Multiple Myeloma
November 27th 2023Belantamab mafodotin plus bortezomib and dexamethasone significantly improved progression-free survival compared with daratumumab plus B-Vd in the second-line treatment of patients with relapsed or refractory multiple myeloma, meeting the primary end point of the phase 3 DREAMM-7 trial.
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