All Oncology News

A supplemental biologics license application seeking the approval of ciltacabtagene autoleucel for use in adult patients with relapsed and lenalidomide-refractory multiple myeloma who have previously received at least 1 line of therapy, including a proteasome inhibitor and an immunomodulatory agent, has been submitted to the FDA.

Researchers at Fox Chase Cancer Center have developed a model that mimics patients’ tumor microenvironment that they believe has the potential to inform therapeutic decision making and presented a case study demonstrating the use of the model recently at the Atlantic Regional Hematopathology Meeting.

The first-in-class EGFR x HER3 bispecific antibody-drug conjugate BL-B01D1 generated antitumor activity and safety in patients with advanced solid tumors, particularly EGFR-mutated and wild-type non–small cell lung cancer and nasopharyngeal carcinoma.

Sotorasib provided consistent benefit over docetaxel in the majority of key prespecified molecularly defined subsets of patients with pretreated KRAS G12C–mutated non–small cell lung cancer enrolled to the phase 3 CodeBreaK 200 trial.

The combination of dabrafenib and trametinib plus navitoclax generated responses and met the co-primary end point for complete response rate vs historical controls in patients with BRAF V600–mutant metastatic melanoma.

Treatment with the combination of epcoritamab, rituximab, and lenalidomide led to responses and durable remissions in patients with relapsed/refractory follicular lymphoma.

The addition of tumor treating fields to standard-of-care immunotherapy or chemotherapy regimens elicited an improvement in overall survival vs SOC therapies alone in patients with metastatic non-small cell lung cancer following progression on or after platinum-based chemotherapy, according to data from the phase 3 LUNAR trial.

Treatment with lisocabtagene maraleucel elicited encouraging responses regardless of prior progression on BTK inhibition or absence of clinical benefit with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, meeting the primary end point of the phase 1/2 TRANSCEND CLL 004 trial.

The combination of mRNA-4157 and pembrolizumab reduced the risk of developing distant metastasis or death by approximately 65% compared with pembrolizumab alone as adjuvant therapy in patients with resected melanoma at high risk of recurrence, according to findings from the phase 2 KEYNOTE-942 trial.

Combination treatment consisting of datopotamab deruxtecan and pembrolizumab with or without platinum-based chemotherapy generated responses as first- or second-line treatment for patients with advanced or metastatic non–small cell lung cancer.

The novel irreversible EGFR exon 20 insertion inhibitor sunvozertinib demonstrated significant clinical activity and similar safety to prior reports in Chinese patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed on prior platinum-based chemotherapy, according to results from the phase 2 WO-KONH6 study.

The 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.

Treatment with avutometinib plus defactinib elicited high responses among patients with recurrent low grade serous ovarian cancer compared with avutometinib monotherapy, supporting the use of the combination in this patient population regardless of KRAS status, according to data from the RAMP 201 trial.

The use of maintenance niraparib enhanced antitumor activity and led to a clinically meaningful increase in progression-free survival vs placebo for patients with newly diagnosed advanced ovarian cancer who displayed measurable residual disease after first-line platinum-based chemotherapy, according to findings from a post hoc subgroup analysis of the phase 3 PRIME study.

Second-line maintenance therapy with niraparib improved overall survival vs active surveillance in patients with recurrent BRCA wild-type ovarian cancer.

The addition of the soluble LAG-3 protein eftilagimod alpha to pembrolizumab produced responses and was well tolerated in patients with metastatic head and neck squamous cell carcinoma.

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

Extended lymphadenectomy at the time of radical cystectomy did not produce a significant improvement in disease-free survival (DFS) or overall survival (OS) vs standard lymphadenectomy for patients with muscle-invasive bladder cancer.

The LAG-3 inhibitor fianlimab plus cemiplimab produced high and consistent tumor responses and a comparable toxicity profile to that of anti–PD-L1 monotherapies in patients with advanced melanoma who were PD-L1 inhibitor–naïve in the advanced setting, according to data from a phase 1 study.

Second-line treatment with axicabtagene ciloleucel significantly improved overall survival compared with high-dose therapy plus autologous stem cell transplant in patients with early relapsed or refractory large B-cell lymphoma.

The addition of sintilimab to chemoradiotherapy demonstrated a significant reduction in the risk of disease recurrence or death, distant metastasis and locoregional recurrence compared with chemoradiotherapy alone as frontline therapy in patients with locally advanced nasopharyngeal carcinoma, according to findings from the phase 3 CONTINUUM trial.

Sacituzumab govitecan demonstrated an overall survival benefit vs physician's choice of treatment in patient with pretreated, endocrine-resistant, hormone receptor–positive, HER2-negative metastatic breast cancer.

The combination of pembrolizumab plus axitinib continued to improve overall survival, progression-free survival, and overall response rate over sunitinib monotherapy in patients with treatment-naïve clear cell renal cell carcinoma.

The addition of atezolizumab to cabozantinib did not improve progression-free survival or overall survival vs cabozantinib alone in patients with advanced renal cell carcinoma who previously received treatment with an immune checkpoint inhibitor, missing the primary end points of the phase 3 CONTACT-03 trial.

The SEZ6-targeted antibody-drug conjugate ABBV-011, when administered at 1 mg/kg every 3 weeks, was found to be well tolerated and to demonstrate early efficacy in patients with relapsed or refractory small cell lung cancer.

Ciltacabtagene 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.

Treatment with fruquintinib plus best supportive care led to improved overall survival and progression-free survival vs placebo plus best supportive care in patients with refractory metastatic colorectal cancer, irrespective of number of prior lines of therapy or type of prior treatment.

Longer follow-up data from the phase 2 ELAINE-2 study demonstrated that treatment with lasofoxifene and abemaciclib resulted in clinically meaningful antitumor activity as well as continued tolerability with no new safety signals for patients with estrogen receptor-positive HER2-negative ESR1-mutated breast cancer who previously received CDK4/6 inhibitors.

Treatment with doxorubicin plus zalifrelimab and balstilimab produced a favorable 6-month progression-free survival rate in patients with difficult-to-treat soft tissue sarcoma subtypes unlikely to respond to doxorubicin or immune checkpoint inhibitor monotherapy.

The combination of trifluridine/tipiracil and bevacizumab did not demonstrate a significant overall survival benefit vs capecitabine plus bevacizumab in patients with unresectable, metastatic colorectal cancer ineligible for intensive chemotherapy.