13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 (Ref) Health Canada granted approval to Merck & Co./MSD's pembrolizumab (anti-PD-1) mono as a neoadjuvant treatment, then continued as adjuvant treatment in combination with RT +/- cisplatin and then as monotherapy for adult patients with resectable locally advanced HNSCC with PD-L1 CPS ≥1. The approval is based on results from the Phase 3 KEYNOTE-689 trial in

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC (Ref) The Phase 3 KEYNOTE-905/EV-303 trial of Merck & Co./MSD's pembrolizumab (Keytruda; anti-PD-1) + Astellas Pharma and Pfizer's enfortumab vedotin (Padcev; anti-Nectin-4 ADC) given before and after radical cystectomy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of EFS, as well as key second

June 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co./MSD's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a neoadjuvant Tx followed by adjuvant pembro Q3W, 3Cy + RT ± cisplatin after surgery, then pembro mono Q3W, 12Cy, for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ What were the factors that influenced the FDA’s decision to limit the label to PD-L1 CPS ≥1? 🎯 The US FDA approved Nuvation Bio’s taletrectinib (ROS1 inhibitor)

May 3rd Week, 2025 Regulatory Events 🎯 Incyte and MacroGenics, Inc.’s retifanlimab (anti-PD-1) + carboplatin + paclitaxel has been approved by the US FDA for the first-line Tx of inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). Retifanlimab has also been approved as a single agent for the Tx of locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemo. (Ref 1) ❓ What is the status of

April 2nd Week, 2025 Regulatory Events 🎯AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan (HER2 ADC) mono has been approved in the EU for the Tx of unresectable/metastatic HR+ve, HER2-low/ultralow breast cancer patients who have received at least one endocrine Tx in the metastatic setting and who are not suitable for endocrine Tx as the next line of Tx. (Ref 1) ❓What is the status of trastuzumab deruxtecan for these patients in other key markets? 🎯AstraZeneca and D

March 4th Week, 2025 Regulatory Events 🎯 CStone Pharmaceuticals submitted a Type II variation application to the EMA for sugemalimab (Cejelmy; anti-PD-L1) to treat stage III NSCLC patients who have not progressed following concurrent or sequential platinum-based CRT. (Ref 1) ❓ How do sugemalimab’s outcomes compare with those of previously approved AstraZeneca’s durvalumab? Special Designations ⭐ Shandong Boan Biotechnology's BA1302 (a first-in-class CD228-directed ADC) has

March 3rd Week, 2025 Regulatory Events 🎯 The US FDA granted traditional approval to Merck & Co./MSD’s pembrolizumab (anti-PD-1) + trastuzumab (anti-HER2) + fluoropyrimidine- and platinum-containing chemo for the first-line treatment of adults with locally advanced, unresectable/metastatic HER2+ve gastric/gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥1 (Ref 1). The regimen was previously granted accelerated approval for this indication in May’21. ❓ Which other re

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies (Ref) MAIA Biotechnology entered into a clinical master supply agreement with Roche for future trials evaluating MAIA’s ateganosine (THIO; telomere-targeting agent) in combination with Roche's atezolizumab (Tecentriq; anti-PD-L1) for the treatment of multiple hard-to-treat cancers. Ateganosine's highly synergistic and effective activity in combination with at

29/04/2025 ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR (Ref 1) ALX Oncology hit with a double blow in first-line R/M SCCHN as their Phase 2 ASPEN-03 & ASPEN-04 trials evaluating evorpacept, a CD47-blocker, in combination with pembrolizumab with or without chemotherapy did not meet the primary endpoints of improved ORR. While data showed trends in improvement versus historical controls, the signals were not strong enough to adva

The first-line metastatic Melanoma market is currently dominated by immune checkpoint inhibitors—BMS' Opdivo + Yervoy, Opdualag, Opdivo, and Merck/MSD's Keytruda. Other treatment options include BRAF/MEK inhibitors (for BRAF+ve pts). Currently, Opdivo + Yervoy is considered as the gold standard with an mOS of 71.9 months; however, it is associated with a high rate of Gr 3/4 TRAEs (62.6%). BMS' Opdualag, a combination of anti-LAG-3 (relatlimab) + anti-PD-1 (nivolumab), entered

Esophageal cancer is the fourteenth most commonly diagnosed cancer and the eighth leading cause of cancer-related death worldwide. The burden of esophageal cancer incidence and mortality is steadily increasing worldwide due to increased prevalence of associated risk factors such as tobacco and alcohol consumption, poor diet, sedentary lifestyle and obesity. Despite advancements in targeted therapies and immunotherapies, the prognosis of Esophageal cancer remains dismal, with

Cervical cancer ranks as the second most common feminine malignant tumor and the second leading cause of death among female cancers worldwide. Nearly 99% of cervical cancer cases are linked to HPV infection, making it largely preventable through HPV vaccination. Despite this, there were 604,127 new global cases and 341,831 deaths in 2020. Localized cervical cancer, which accounts for about 43% of all cases, has a five-year relative survival rate of 91.2%. However, locally adv

PD-(L)1 axis inhibits CAR-T cell activation, proliferation, survival, and functionality. Thus, CAR-T mediated direct targeting of the PD-(L)1 immunosuppressive axis or modulation of the axis along with CAR-T therapy holds a huge promise to unleash the full potential of CAR-Ts. Multiple strategies are under investigation to target PD-(L)1 immunosuppressive axis to increase CAR-T therapy efficacy. We have grouped the strategies under the following three broad categories, Combin

Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer and the 4th leading cause of cancer death worldwide in 2020, with an observed trend of increasing incidence rates in younger adults (<50 years). Despite therapeutic progress, the survival rate for gastric cancer patients remains low, highlighting the unmet need for treatments of further potential. In this concise infographic, we highlight the

Breast cancer is the most commonly diagnosed cancer worldwide with a steady increase in incidence rate over the past decades. It is estimated that, if the current trends remain unchanged, the burden of breast cancer is set to grow to over 3 million new cases and 1 million deaths per year by 2040 as a result of population growth and ageing alone. The infographic highlights the current key options in Breast cancer's evolving treatment paradigm with a glimpse of the emerging the

In observance of Sarcoma Awareness Month, Oncofocus is pleased to present a user-friendly infographic. This comprehensive visual presentation aims to elucidate crucial aspects such as epidemiology, key treatment options, and emerging therapies related to sarcoma. By staying informed and actively participating in sharing this publicly accessible infographic, we can collectively raise awareness about sarcoma and its implications. Together, let us make a positive impact during S

In acknowledgment of Melanoma Awareness Month, Oncofocus presents a user-friendly infographic. It showcases a glimpse into top-level epidemiology data, key treatment options, and emerging therapies. Stay informed and help spread melanoma awareness with this publicly accessible infographic.

In recognition of Head and Neck Cancer Awareness Month, Oncofocus has released a concise and easy-to-read infographic that outlines the current approved therapies and noteworthy emerging therapies. Stay informed and help spread HNC awareness with this publicly accessible infographic.

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma, or bile duct cancer, affects approximately 8,000 individuals annually in the United States, while gallbladder cancer is even less common, with an incidence rate of about 2 per 100,000 people. These cancers are frequently diagnosed at advanced stages, leading to poor prognoses. In the US and EU, treatment options remain scarce, although recen