Kristi Rosa

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

Articles

TP-3654 Demonstrates Favorable Tolerability, Early Clinical Activity in R/R Myelofibrosis

December 19th 2023

The 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.

FDA Issues Complete Response Letter to Cosibelimab for Cutaneous Squamous Cell Carcinoma

December 18th 2023

The 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.

OBX-115 Elicits Responses in Advanced or Metastatic Melanoma

December 16th 2023

The 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.

FDA Grants Fast Track Status to Naporafenib Plus Trametinib for Advanced NRAS-Mutated Melanoma

December 15th 2023

The 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.

RP1 Plus Cemiplimab Misses Response End Points in Locally Advanced or Metastatic CSCC

December 14th 2023

The 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.

Dostarlimab Plus Chemo Granted EU Approval for dMMR/MSI-H Endometrial Cancer

December 14th 2023

The 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.

Anito-Cel Elicits Responses With Manageable Safety in Relapsed/Refractory Multiple Myeloma

December 12th 2023

Anitocabtagene autoleucel showcased early efficacy with acceptable toxicity in patients with relapsed and/or refractory multiple myeloma—even in those with high-risk features.

Axatilimab Elicits Responses With Manageable Safety in Recurrent/Refractory cGVHD

December 11th 2023

Axatilimab 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.

Pirtobrutinib Demonstrates Durable Efficacy in Covalent BTK Inhibitor–Pretreated CLL/SLL

December 10th 2023

Pirtobrutinib 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.

Atezolizumab Plus Neoadjuvant HP/Chemo Does Not Significantly Improve pCR in HER2+ Breast Cancer

December 8th 2023

The 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.

Phase 3 KEYLYNK-008 Trial of Pembrolizumab Plus Olaparib in Metastatic Squamous NSCLC to Stop for Futility

December 8th 2023

The phase 3 KEYLYNK-008 trial evaluating pembrolizumab plus olaparib in patients with metastatic squamous non–small cell lung cancer will be discontinued for futility, according to an announcement from Merck.

Inavolisib Plus Palbociclib and Fulvestrant Improves PFS in PIK3CA-Mutated HR+ Breast Cancer

December 7th 2023

The 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.

Neoadjuvant Pembrolizumab Plus Chemo Improves pCR Across Key ER+ Breast Cancer Subgroups

December 6th 2023

The 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.

FDA Approves Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

December 6th 2023

The FDA has approved iptacopan (Fabhalta) for use in adult patients with paroxysmal nocturnal hemoglobinuria.

FDA Grants Priority Review to Mirvetuximab Soravtansine in FRα+ Platinum-Resistant Ovarian Cancer

December 5th 2023

The 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.

FDA Grants Priority Review to Frontline Nivolumab Plus Chemo for Unresectable or Metastatic Urothelial Carcinoma

December 5th 2023

The FDA has granted priority review to a supplemental biologics license application seeking the approval of nivolumab plus cisplatin-based chemotherapy as a frontline treatment option for adult patients with unresectable or metastatic urothelial carcinoma.

FDA Grants Orphan Drug Designation to LP-284 for High-Grade B-Cell Lymphomas

December 4th 2023

The FDA has granted orphan drug designation to LP-284 for use in the treatment of patients with high-grade B-cell lymphoma harboring MYC and BCL2 rearrangements.

Sintilimab Triplet Demonstrates Efficacy With Acceptable Safety in pMMR/MSS CRC

November 30th 2023

The 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.

First-Line Pembrolizumab Demonstrates Durable Clinical Benefit in MSI-H/dMMR mCRC

November 30th 2023

Pembrolizumab 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.

Perioperative Enfortumab Vedotin Shows Antitumor Activity in Cisplatin-Ineligible MIBC

November 29th 2023

Perioperative enfortumab vedotin elicited responses in cisplatin-eligible patients with muscle-invasive bladder cancer.