Kristi Rosa

Managing Editor, 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 serves as the main digital news writer for OncLive. Prior to working at the company, she served as lead copywriter and marketing coordinator at The Strand Theater. Email: krosa@onclive.com

Articles

Agenus Withdraws BLA for Balstilimab in Metastatic Cervical Cancer

October 22nd 2021

The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

Oncopeptides Withdraws Melphalan Flufenamide Myeloma Indication in the United States

October 22nd 2021

Oncopeptides AB has made the decision to withdraw the indication of melphalan flufenamide in combination with dexamethasone in select adult patients with relapsed or refractory multiple myeloma from the US market.

TAS-102 Plus Bevacizumab Misses PFS End Point in Frontline Unresectable Metastatic CRC

October 22nd 2021

The frontline combination of trifluridine/tipiracil and bevacizumab was not found to result in a significant improvement in progression-free survival over capecitabine and bevacizumab in patients with unresectable metastatic colorectal cancer who are not eligible to receive intensive therapy, missing the primary end point of the phase 3 SOLSTICE trial.

Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC

October 22nd 2021

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

FDA Approves Companion Diagnostic for Adjuvant Atezolizumab in Stage II to IIIA NSCLC

October 22nd 2021

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

EC-18 Reduces Duration and Incidence of Chemoradiation-Induced Oral Mucositis in Head and Neck Cancer

October 21st 2021

Treatment with the small molecule oral immunomodulator EC-18 resulted in a reduction in both the duration and incidence of severe oral mucositis in patients with head and neck cancer who are undergoing concurrent chemoradiation.

Nivolumab/Chemo Approved in Europe for HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

October 21st 2021

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

Elacestrant Improves PFS Over SOC in ER+ Advanced or Metastatic Breast Cancer

October 20th 2021

Elacestrant monotherapy improved progression-free survival over standard-of-care (SOC) treatment in patients with estrogen receptor–positive, HER2-negative breast cancer, including those whose tumors harbored ESR1 mutations, meeting the primary end points of the phase 3 EMERALD trial.

N-803 Plus Intravesical BCG Produces 57% DFS in BCG-Unresponsive Papillary Bladder Cancer

October 20th 2021

Intravesical Bacillus Calmette–Guérin in combination with N-803 resulted in a 12-month disease-free survival rate of 57% in patients with BCG-unresponsive high-grade papillary non–muscle invasive bladder cancer, meeting the primary end point for cohort B of the phase 2/3 QUILT 3.032 trial.

Avasopasem Misses the Mark for Radiotherapy-Induced Severe Oral Mucositis in Head and Neck Cancer

October 19th 2021

The dismutase mimetic avasopasem manganese was not found to significantly reduce the incidence of severe oral mucositis in patients with locally advanced head and neck cancer who were receiving standard-of-care radiotherapy, missing the primary end point of the phase 3 ROMAN trial.

Bicycle Toxin Conjugates Showcase Early Activity and Tolerability in Urothelial, Ovarian Cancers

October 19th 2021

The bicycle toxin conjugates BT5528 and BT8009 have showcased preliminary signs of antitumor activity and encouraging tolerability when administered to patients with solid tumors such as urothelial cancer and ovarian cancer.

Inguinofemoral Radiotherapy Represents Safe Alternative to Lymphadenectomy in Vulvar Cancer With Micrometastases

October 18th 2021

Inguinofemoral radiotherapy could potentially spare patients with vulvar cancer and sentinel node micrometastases from the morbidity of a lymphadenectomy.

FDA Grants Orphan Drug Designation to Bispecific Antibody LAVA-051 for CLL

October 18th 2021

The FDA has granted an orphan drug designation to LAVA-051, a CD1d-targeted Gammabody, for the treatment of patients with chronic lymphocytic leukemia.

Novel Sintilimab Combo Significantly Improves PFS in EGFR-Mutated Nonsquamous NSCLC

October 18th 2021

The combination of sintilimab, a bevacizumab biosimilar injection, and chemotherapy resulted in a significant improvement in progression-free survival in patients with EGFR-mutated, nonsquamous, non–small cell lung cancer that as progressed following treatment with an EGFR TKI, meeting the primary end point of the phase 3 ORIENT-31 trial.

Pembrolizumab/Lenvatinib Approaches EU Approval for Select RCC and Endometrial Carcinoma

October 15th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding approval of the combination of pembrolizumab and lenvatinib for 2 indications: select patients with renal cell carcinoma and select patients with endometrial carcinoma.

Tremelimumab Plus Durvalumab Improves Survival in Frontline Unresectable HCC

October 15th 2021

A single, high priming dose of tremelimumab plus durvalumab resulted in a statistically significant and clinically meaningful improvement in overall survival vs sorafenib when used in the frontline treatment of patients with unresectable hepatocellular carcinoma who had not previously received systemic therapy and were not eligible for localized treatment.

FDA Approves Adjuvant Atezolizumab for Select Stage II to IIIA NSCLC

October 15th 2021

The FDA has approved atezolizumab for use as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

FDA Greenlights Companion Diagnostic for Adjuvant Abemaciclib Plus Endocrine Therapy in High-Risk Early Breast Cancer

October 14th 2021

The FDA has approved the Ki-67 IHC MIB-1 pharmDx test to assist in determining which patients with early breast cancer who are at high risk of disease recurrence might benefit from adjuvant treatment with abemaciclib plus endocrine therapy.

Shorter Obinutuzumab Infusion Approved in Europe for Advanced Follicular Lymphoma

October 14th 2021

The European Medicines Agency has approved a shorter, 90-minute infusion time for obinutuzumab to be given in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.

CAR T-cell Therapy CTX110 Shows Early Promise for Relapsed/Refractory CD19+ B-cell Malignancies

October 13th 2021

The allogeneic CD19-targeted CAR T-cell therapy CTX110 was found to elicit encouraging responses with favorable tolerability in patients with relapsed or refractory B-cell malignancies, according to data from the phase 1 CARBON trial.