Latest news with #SCLC
Yahoo
2 days ago
- Health
- Yahoo
ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers
Small cell lung cancer (SCLC) accounts for 10-15% of all lung cancer cases annually, with 250,000 incident cases diagnosed every year and 200,000 deaths occurring. With such a high healthcare burden, rapid advancements have been made with the advent of programmed cell death protein-1 checkpoint inhibition and immunotherapy, although they have only been proven successful in the first-line paradigm. Unlike non-small cell lung cancer (NSCLC), the treatment options for SCLC are more limited, as it is more aggressive and develops resistance to available treatments rapidly. One of the current standards of care (SOC) is the use of platinum-based chemotherapy such as cisplatin in combination with Roche's Tecentriq or AstraZeneca's Imfinzi in the first-line treatment for extensive-stage SCLC (ES-SCLC). Following treatment, many patients with NSCLC will develop platinum resistance through strengthened DNA-repair capabilities and reduced chemotherapy uptake in the cancerous cells. Amgen's Imdelltra, a bispecific T-cell engager (BiTE) that targets Delta-like canonical Notch ligand 3 (DLL3) and cluster of differentiation 3 (CD3) receptors, received US Food and Drug Administration approval for the treatment of patients with ES-SCLC following disease progression or following platinum-based chemotherapy, based on results from the DeLLphi-301 trial. While the approval is a historic event for the BiTE drug class in solid tumours, the market share opportunity is restricted as DeLLphi-301 was a Phase II trial with only one arm and no comparator. Results from the American Society of Clinical Oncology 2025 have shown the latest in Imdelltra's clinical results from the DeLLphi-304 trial. DeLLphi-304 enrolled 254 patients receiving Imdelltra and 255 receiving one of the following: topotecan, amrubicin, or Jazz Pharmaceutical's Zepzelca. Zepzelca and topotecan are preferred systemic treatment options for SCLC. Imdelltra was found to increase overall survival by 5.3 months (hazard ratio: 0.60, P<0.001) and increase median progression-free survival. There was also a large difference in grade 3 treatment-related adverse events, with Imdelltra reducing the rate by 35% compared to the control arm. Absent any competing immunotherapies with a preferred National Comprehensive Cancer Network opinion, Imdelltra is expected to be an attractive option for many patients looking to enhance their care. The annual cost of Imdelltra therapy totals $167,600 per patient. As a result, Imdelltra will likely struggle to receive reimbursement outside of the US. Despite the high cost, the clinical benefits are clear and Imdelltra's US market share uptake will be enhanced with these positive results, particularly owing to its more manageable safety profile when compared to existing options for this segment. Leading data and analytics company GlobalData's indication-based forecast shows Imdelltra will reach $1.76bn globally by 2031. "ASCO 2025: DeLLphi-304 helps Amgen to pave the way for BiTEs in solid cancers" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
4 days ago
- Politics
Judge weighs government's request to unseal records of FBI's surveillance of Martin Luther King Jr.
WASHINGTON -- A federal judge is weighing a request from the Trump administration to unseal records of the FBI's surveillance of Martin Luther King Jr. — files that the civil rights leader's relatives want to keep under wraps in the national archives. U.S. District Judge Richard Leon in Washington, D.C., said during a hearing on Wednesday that he wants to see an inventory of the records before deciding whether the government can review them for possible release to the public. 'This is delicate stuff,' Leon said. 'We're going to go slowly. Little steps.' Justice Department attorneys have asked Leon to end a sealing order for the records nearly two years ahead of its expiration date. A department attorney said the administration is only interested in releasing files related to King's assassination. The Southern Christian Leadership Conference, which King led, is opposed to unsealing any of the records for privacy reasons. The organization's lawyers said King's relatives also want to keep the files under seal. In 1977, a court order directed the FBI to collect records about its surveillance and monitoring of King and turn them over to the National Archives and Records Administration. The order required the records to remain under seal for 50 years — until Jan. 31, 2027. In January, President Donald Trump ordered Attorney General Pam Bondi to review and publicly release documents about King's assassination 'because the American people have an interest in full transparency about this key historic event,' government lawyers wrote. 'To maximize this transparency objective, the records sealed in this case should be part of the Attorney General's review,' they added. SCLC attorneys said the FBI tried to discredit King and their organization by illegally wiretapping King's home, SCLC offices and hotel rooms where King met with other SCLC officials. Unsealing records of those recordings is contrary to the interests of SCLC, the King family and the public, the lawyers argued. 'Since its inception, this case has been about government overreach,' said SCLC attorney Sumayya Saleh. Justice Department attorney Johnny Walker said the administration has no intention of releasing any personal communications or privileged records contained in the files. 'Thankfully, I am not here to defend the allegations in the underlying complaint,' Walker told the judge. Nobody involved in the litigation knows what's in the archives and whether any of it relates to King's assassination. 'It could be easy. There could be nothing, and then we just all go away,' Walker said. 'It's not going to happen overnight,' the judge said. 'The court is going to move very carefully.' King was shot and killed on April 4, 1968, while standing on the balcony of a motel in Memphis, Tennessee. In 1976, the SCLC and Bernard Lee, who was King's executive assistant at the organization, filed a lawsuit to challenge the legality of the FBI's surveillance. The 1977 court order required the FBI to compile records of its telephone wiretapping operations, between 1963 and 1968, at King's home and at the SCLC offices in Atlanta and New York. Bernice King, the civil rights leader's youngest daughter, said in a court filing that she hopes the files are permanently sealed or destroyed. 'It is unquestionable that my father was a private citizen, not an elected official, who enjoyed the right to privacy that should be afforded to all private citizens of this country,' she said. 'To not only be unjustifiably surveilled, but to have the purported surveillance files made public would be a travesty of justice.'
Hamilton Spectator
4 days ago
- Politics
- Hamilton Spectator
Judge weighs government's request to unseal records of FBI's surveillance of Martin Luther King Jr.
WASHINGTON (AP) — A federal judge is weighing a request from the Trump administration to unseal records of the FBI's surveillance of Martin Luther King Jr. — files that the civil rights leader's relatives want to keep under wraps in the national archives. U.S. District Judge Richard Leon in Washington, D.C., said during a hearing on Wednesday that he wants to see an inventory of the records before deciding whether the government can review them for possible release to the public. 'This is delicate stuff,' Leon said. 'We're going to go slowly. Little steps.' Justice Department attorneys have asked Leon to end a sealing order for the records nearly two years ahead of its expiration date. A department attorney said the administration is only interested in releasing files related to King's assassination. The Southern Christian Leadership Conference, which King led, is opposed to unsealing any of the records for privacy reasons. The organization's lawyers said King's relatives also want to keep the files under seal. In 1977, a court order directed the FBI to collect records about its surveillance and monitoring of King and turn them over to the National Archives and Records Administration. The order required the records to remain under seal for 50 years — until Jan. 31, 2027. In January, President Donald Trump ordered Attorney General Pam Bondi to review and publicly release documents about King's assassination 'because the American people have an interest in full transparency about this key historic event,' government lawyers wrote . 'To maximize this transparency objective, the records sealed in this case should be part of the Attorney General's review,' they added. SCLC attorneys said the FBI tried to discredit King and their organization by illegally wiretapping King's home, SCLC offices and hotel rooms where King met with other SCLC officials. Unsealing records of those recordings is contrary to the interests of SCLC, the King family and the public, the lawyers argued . 'Since its inception, this case has been about government overreach,' said SCLC attorney Sumayya Saleh. Justice Department attorney Johnny Walker said the administration has no intention of releasing any personal communications or privileged records contained in the files. 'Thankfully, I am not here to defend the allegations in the underlying complaint,' Walker told the judge. Nobody involved in the litigation knows what's in the archives and whether any of it relates to King's assassination. 'It could be easy. There could be nothing, and then we just all go away,' Walker said. 'It's not going to happen overnight,' the judge said. 'The court is going to move very carefully.' King was shot and killed on April 4, 1968, while standing on the balcony of a motel in Memphis, Tennessee. In 1976, the SCLC and Bernard Lee, who was King's executive assistant at the organization, filed a lawsuit to challenge the legality of the FBI's surveillance. The 1977 court order required the FBI to compile records of its telephone wiretapping operations, between 1963 and 1968, at King's home and at the SCLC offices in Atlanta and New York. Bernice King, the civil rights leader's youngest daughter, said in a court filing that she hopes the files are permanently sealed or destroyed. 'It is unquestionable that my father was a private citizen, not an elected official, who enjoyed the right to privacy that should be afforded to all private citizens of this country,' she said. 'To not only be unjustifiably surveilled, but to have the purported surveillance files made public would be a travesty of justice.' Trump's Jan. 23 executive order also called for declassifying records about the assassinations of President John F. Kennedy and Sen. Robert F. Kennedy . Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .
Winnipeg Free Press
4 days ago
- Politics
- Winnipeg Free Press
Judge weighs government's request to unseal records of FBI's surveillance of Martin Luther King Jr.
WASHINGTON (AP) — A federal judge is weighing a request from the Trump administration to unseal records of the FBI's surveillance of Martin Luther King Jr. — files that the civil rights leader's relatives want to keep under wraps in the national archives. U.S. District Judge Richard Leon in Washington, D.C., said during a hearing on Wednesday that he wants to see an inventory of the records before deciding whether the government can review them for possible release to the public. 'This is delicate stuff,' Leon said. 'We're going to go slowly. Little steps.' Justice Department attorneys have asked Leon to end a sealing order for the records nearly two years ahead of its expiration date. A department attorney said the administration is only interested in releasing files related to King's assassination. The Southern Christian Leadership Conference, which King led, is opposed to unsealing any of the records for privacy reasons. The organization's lawyers said King's relatives also want to keep the files under seal. In 1977, a court order directed the FBI to collect records about its surveillance and monitoring of King and turn them over to the National Archives and Records Administration. The order required the records to remain under seal for 50 years — until Jan. 31, 2027. In January, President Donald Trump ordered Attorney General Pam Bondi to review and publicly release documents about King's assassination 'because the American people have an interest in full transparency about this key historic event,' government lawyers wrote. 'To maximize this transparency objective, the records sealed in this case should be part of the Attorney General's review,' they added. SCLC attorneys said the FBI tried to discredit King and their organization by illegally wiretapping King's home, SCLC offices and hotel rooms where King met with other SCLC officials. Unsealing records of those recordings is contrary to the interests of SCLC, the King family and the public, the lawyers argued. 'Since its inception, this case has been about government overreach,' said SCLC attorney Sumayya Saleh. Justice Department attorney Johnny Walker said the administration has no intention of releasing any personal communications or privileged records contained in the files. 'Thankfully, I am not here to defend the allegations in the underlying complaint,' Walker told the judge. Nobody involved in the litigation knows what's in the archives and whether any of it relates to King's assassination. 'It could be easy. There could be nothing, and then we just all go away,' Walker said. 'It's not going to happen overnight,' the judge said. 'The court is going to move very carefully.' King was shot and killed on April 4, 1968, while standing on the balcony of a motel in Memphis, Tennessee. In 1976, the SCLC and Bernard Lee, who was King's executive assistant at the organization, filed a lawsuit to challenge the legality of the FBI's surveillance. The 1977 court order required the FBI to compile records of its telephone wiretapping operations, between 1963 and 1968, at King's home and at the SCLC offices in Atlanta and New York. Bernice King, the civil rights leader's youngest daughter, said in a court filing that she hopes the files are permanently sealed or destroyed. 'It is unquestionable that my father was a private citizen, not an elected official, who enjoyed the right to privacy that should be afforded to all private citizens of this country,' she said. 'To not only be unjustifiably surveilled, but to have the purported surveillance files made public would be a travesty of justice.' Trump's Jan. 23 executive order also called for declassifying records about the assassinations of President John F. Kennedy and Sen. Robert F. Kennedy.
Yahoo
4 days ago
- Politics
- Yahoo
Judge weighs government's request to unseal records of FBI's surveillance of Martin Luther King Jr.
WASHINGTON (AP) — A federal judge is weighing a request from the Trump administration to unseal records of the FBI's surveillance of Martin Luther King Jr. — files that the civil rights leader's relatives want to keep under wraps in the national archives. U.S. District Judge Richard Leon in Washington, D.C., said during a hearing on Wednesday that he wants to see an inventory of the records before deciding whether the government can review them for possible release to the public. 'This is delicate stuff,' Leon said. 'We're going to go slowly. Little steps.' Justice Department attorneys have asked Leon to end a sealing order for the records nearly two years ahead of its expiration date. A department attorney said the administration is only interested in releasing files related to King's assassination. The Southern Christian Leadership Conference, which King led, is opposed to unsealing any of the records for privacy reasons. The organization's lawyers said King's relatives also want to keep the files under seal. In 1977, a court order directed the FBI to collect records about its surveillance and monitoring of King and turn them over to the National Archives and Records Administration. The order required the records to remain under seal for 50 years — until Jan. 31, 2027. In January, President Donald Trump ordered Attorney General Pam Bondi to review and publicly release documents about King's assassination 'because the American people have an interest in full transparency about this key historic event,' government lawyers wrote. 'To maximize this transparency objective, the records sealed in this case should be part of the Attorney General's review,' they added. SCLC attorneys said the FBI tried to discredit King and their organization by illegally wiretapping King's home, SCLC offices and hotel rooms where King met with other SCLC officials. Unsealing records of those recordings is contrary to the interests of SCLC, the King family and the public, the lawyers argued. 'Since its inception, this case has been about government overreach,' said SCLC attorney Sumayya Saleh. Justice Department attorney Johnny Walker said the administration has no intention of releasing any personal communications or privileged records contained in the files. 'Thankfully, I am not here to defend the allegations in the underlying complaint,' Walker told the judge. Nobody involved in the litigation knows what's in the archives and whether any of it relates to King's assassination. 'It could be easy. There could be nothing, and then we just all go away,' Walker said. 'It's not going to happen overnight,' the judge said. 'The court is going to move very carefully.' King was shot and killed on April 4, 1968, while standing on the balcony of a motel in Memphis, Tennessee. In 1976, the SCLC and Bernard Lee, who was King's executive assistant at the organization, filed a lawsuit to challenge the legality of the FBI's surveillance. The 1977 court order required the FBI to compile records of its telephone wiretapping operations, between 1963 and 1968, at King's home and at the SCLC offices in Atlanta and New York. Bernice King, the civil rights leader's youngest daughter, said in a court filing that she hopes the files are permanently sealed or destroyed. 'It is unquestionable that my father was a private citizen, not an elected official, who enjoyed the right to privacy that should be afforded to all private citizens of this country,' she said. 'To not only be unjustifiably surveilled, but to have the purported surveillance files made public would be a travesty of justice.' Trump's Jan. 23 executive order also called for declassifying records about the assassinations of President John F. Kennedy and Sen. Robert F. Kennedy.
