Caroline Seymour

The shift away from accepting only positive overall survival (OS) data from phase 3 trials as the pathway toward regulatory approval has been the biggest takeaway from 2021 in lung cancer.

Zandelisib demonstrated significant activity and an encouraging preliminary safety profile in patients with relapsed/refractory follicular lymphoma who have received at least 2 prior systemic therapies.

The FDA has granted a breakthrough therapy designation to patritumab deruxtecan for the treatment of patients with metastatic or locally advanced EGFR-mutated non–small cell lung cancer with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

Lee S. Schwartzberg, MD, discusses the culmination of research with androgen-targeted agents in metastatic androgen receptor–positive, estrogen receptor–positive breast cancer and ongoing research that could lead to a paradigm shift in the second-line setting.

Positive findings from the phase 3 CLEAR, CheckMate 9ER, CheckMate 214, and KEYNOTE-426 trials have led to the swift adoption of combination immunotherapy as the preferred frontline standard of care for the treatment of patients with advanced clear cell renal cell carcinoma, which has been further enforced by a recommendation from the European Association of Urology RCC Guidelines Panel.

A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare or the use of fam-trastuzumab deruxtecan-nxki as a treatment in select patients with HER2-positive unresectable or recurrent breast cancer.

Preliminary research with datopotamab deruxtecan has shown a promising, unprecedented duration of response in heavily pretreated patients with non–small cell lung cancer.

R. Lor Randall, MD, FACS, elaborates on the results of a study and provided insight into future research directions in Ewing sarcoma

Treatment with the CD123- and CD3-engaging bispecific antibody APVO436 caused cytokine release syndrome in approximately 1 of 5 patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome but was generally well managed with steroids.

The addition of tafasitamab and lenalidomide to rituximab, cyclophosphamide, doxorubicin, and prednisone demonstrated increased but generally comparable adverse effects and higher, prolonged, and deeper responses vs the combination of tafasitamab and R-CHOP alone in patients with previously untreated diffuse large B-cell lymphoma.

The addition of polatuzumab vedotin-piiq to R-CHP led to a 27% reduction in the risk of progression or death vs R-CHOP in patients with previously untreated, intermediate- and high-risk diffuse large B-cell lymphoma.

Asciminib demonstrated a consistent improvement in major molecular response rate and depth of response vs bosutinib in patients with chronic-phase chronic myeloid leukemia without any new or worsening adverse effects.

Frontline fixed-duration treatment with ibrutinib plus venetoclax led to deeper and prolonged rates of undetectable minimal residual disease in the bone marrow and peripheral blood, leading to fewer relapses in the first year post-treatment vs chlorambucil plus obinutuzumab in elderly and unfit patients with chronic lymphocytic leukemia.

Trastuzumab deruxtecan led to prolonged progression-free survival and higher responses vs trastuzumab emtansine as second-line therapy in patients with HER2-positive metastatic breast cancer across all patients subgroups, including those with and without baseline brain metastases.

Genomic alterations identified through multigene sequencing, classified in the I/II tiers of the ESMO Scale of Actionability of Molecular Targets, and paired with matching targeted therapy led to a significant improvement in progression-free survival vs maintenance chemotherapy in patients with HER2-negative metastatic breast cancer.

Image-guided intensity-modulated radiotherapy caused less toxicity compared with three-dimensional conformal radiation therapy with no difference in disease outcomes in patients with cervical cancer undergoing postoperative radiation therapy.

The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.

The FDA has granted a priority review designation to a supplemental new drug application for the use of olaparib as adjuvant therapy in patients with BRCA-mutated, high-risk, HER2-negative early breast cancer who have previously received neoadjuvant or adjuvant chemotherapy.

The combination of CG0070 and pembrolizumab was well tolerated and demonstrated early signals of activity in patients with Bacille Calmette-Guérin-unresponsive non–muscle invasive bladder cancer.

Lisocabtagene maraleucel demonstrated durable responses and a favorable safety profile in patients with relapsed/refractory large B-cell lymphoma.

Manojkumar Bupathi, MD, MS, shares the main highlights from the meeting, which centered on frontline, second, and later-line treatment of metastatic urothelial carcinoma and metastatic renal cell carcinoma.

The combination of cabozantinib and atezolizumab led to a statistically significant improvement in progression-free survival and a numerical improvement in overall survival vs sorafenib as frontline treatment in patients with advanced hepatocellular carcinoma, according to findings from the first planned analysis of the phase 3 COSMIC-312 trial.

The FDA has granted a priority review designation to a biologics license application for betibeglogene autotemcel for the treatment of adult, adolescent, and pediatric patients with β-thalassemia across all genotypes who require regular red blood cell transfusions.

Three doses of the SARS-CoV2 vaccine were shown to be safe and effective in patients with lung cancer, particularly in those with minimal serologic response after receiving only 2 doses.

Corey S. Cutler, MD, MPH, FRCPC, discusses the diagnostic and treatment landscape of chronic graft-vs-host disease.

Molecular markers, risk, and response are being used to better tailor escalated and de-escalated treatment approaches for women with breast cancer.

For patients with advanced clear cell renal cell carcinoma, it will be of utmost importance to recognize the vari­ation in response and type of progression with first-line therapy, the patient’s charac­teristics and motivations, and the promise of new agents and combinations.

Luis E. Raez, MD, FACP, FCCP, discusses frontline immunotherapeutic options in NSCLC, management strategies for patients with stage III disease, targeted approaches for patients with EGFR- and ALK-positive NSCLC, and how the field of SCLC is navigating newly available therapies.

The innate cell engager AFM24 showed greater efficacy in eliciting antibody-dependent cellular phagocytosis of EGFR wild-type and KRAS-mutant tumor cells compared with cetuximab.

Although BCMA-directed CAR T-cell therapy has shown early and deep responses in patients with relapsed/refractory multiple myeloma, there is much more to learn about optimal cytokine release syndrome and neurotoxicity management and treatment sequencing, particularly as off-the-shelf T-cell therapies, bispecific antibodies, and non–BCMA-directed therapies become available.