As Seagen readies itself for its impending acquisition by Pfizer, a significant triumph emerges for the company’s cancer drug Padcev, which is partnered with Astellas. In a groundbreaking development, Padcev, when used in combination with Merck’s Keytruda, has achieved a pivotal victory in previously untreated metastatic bladder cancer.
The study yielded remarkable results, demonstrating the superiority of the Padcev-Keytruda combo over chemotherapy in terms of both overall survival and progression-free survival. An independent data monitoring committee, during an interim analysis, determined that the combination’s life-extending benefits surpassed the pre-defined efficacy threshold, marking a pivotal moment for this therapeutic approach.
These outcomes have the potential to extend the reach of this combination therapy to patients who qualify for platinum-based chemotherapies, such as cisplatin or carboplatin, irrespective of their PD-L1 status.
“This study has the potential to be practice-changing and offer a new standard of care for first-line metastatic bladder cancer. We look forward to presenting the results at an upcoming medical conference and discussing with regulators in order to get this medicine to patients as soon as possible.”
– Dr. Roger Dansey, Head of Research and Development at Seagen
Notably, in April, the Padcev-Keytruda combination received accelerated FDA approval for the treatment of first-line platinum-ineligible patients. With the inclusion of the cisplatin-eligible population, the potential market for Padcev could nearly double, exceeding $5 billion worldwide, according to insights from William Blair analysts.
Furthermore, the analysts anticipate “rapid adoption” by physicians if the combination therapy secures approval. These results also present an opportunity for Pfizer, as the Federal Trade Commission continues to review Pfizer’s proposed $43 billion acquisition of Seagen. Both companies anticipate finalizing the transaction by late 2023 or early 2024, as indicated in Seagen’s filing in July.
Padcev achieved full approval in 2021, initially receiving conditional approval for the same patient population as a third-line therapy, intended for patients who had already undergone platinum-based chemotherapy and a PD-1/PD-L1 checkpoint inhibitor. Simultaneously, it was granted approval for second-line treatment in adults who were ineligible for cisplatin-based chemotherapy. This recent success underscores the potential of Padcev as a transformative force in the field of metastatic bladder cancer treatment.