On June 2, 2025 Bayer reported detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12 compared to placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer (Press release, Bayer, JUN 2, 2025, View Source [SID1234653655]). Key secondary endpoints showed statistically significant improvement of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo. These data are being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 – June 3 in Chicago, IL, USA, and have been simultaneously published in the New England Journal of Medicine (NEJM). OASIS-4 is the first pivotal international Phase III study to assess the safety and efficacy of elinzanetant for the treatment of moderate to severe VMS associated with endocrine therapy for the treatment or prevention of HR+ breast cancer.

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"Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment," said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon Portugal. "With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options."

In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline to week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data1,2,3 on elinzanetant in postmenopausal women with VMS, with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.

The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001). Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo.

"The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may impact their ability to adhere to other treatments," said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. "Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women."

Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis.4 Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence.5 Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy.

Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the Journal of the American Medical Association (JAMA)3 in August 2024. Detailed results of the Phase III study OASIS-3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world.

About the Elinzanetant Clinical Development Program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of VMS due to menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.

About Elinzanetant
Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause, which is highly relevant from both a healthcare and socio-economic perspective.

On June 2, 2025 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported initial Phase 1 safety and efficacy data from the Phase 1/2 Agni-01 multicenter study of OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma (NCT06060613) (Press release, Obsidian Therapeutics, JUN 2, 2025, View Source [SID1234653654]). These data, summarized below, will be presented in a rapid oral presentation (abstract 9517) delivered by Jason A. Chesney, M.D., Ph.D., Director and Chief Administrative Officer of UofL Health – Brown Cancer Center/Oncology Service Line at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Obsidian is also presenting a poster for abstract 9519 summarizing translational data from the Phase 1 first-in-human single-center study of OBX-115 (NCT05470283, enrollment completed) in ICI-resistant advanced melanoma.

Summary of OBX-115 Safety and Efficacy Data (March 26, 2025 data cutoff):

Advancing a More Patient-centric TIL Cell Therapy Regimen in Heavily Pre-treated Advanced Melanoma Patient Population

Patients had disease that was predominantly ICI primary-resistant, with a median of 4 (range, 1–6) lines of prior systemic therapy, including a median of 2 (1–5) lines of prior ICI therapy (n=11).
10 patients received low-dose lymphodepletion (approximately 50% less Cyclophosphamide relative to non-engineered TIL), including 1 in the outpatient setting.
Acetazolamide (ACZ) redosing following initial OBX-115 infusion to drive re-activation of OBX-115 cells was tolerable and safe enough to administer at home.
OBX-115 Continues to Deliver Positively Differentiated Safety Profile Relative to Non-engineered TIL; No IL2, No Treatment-related Mortality:

No dose-limiting toxicities were observed at any dose level.
No Grade 4 or higher nonhematologic treatment-related adverse events (TRAEs) were reported; 5 patients experienced limited Grade 3 nonhematologic TRAEs.
No confirmed events of cytokine release syndrome or infusion-related reaction higher than Grade 2; no capillary leak syndrome or immune effector cell-associated neurotoxicity syndrome were reported.
No treatment-related ICU transfer, no treatment-related mortality.
OBX-115 Maintains Consistent Efficacy Profile Without IL2 and With Low-dose Lymphodepletion in Anti-PD-1-resistant Advanced Melanoma; Dose Level 3 (RP2D) To Be Further Explored in Phase 2

Encouraging efficacy profile observed at the RP2D (n=6)
66.7% ORR, including 1 confirmed CR and 3 confirmed PRs (investigator-assessed RECIST 1.1 criteria)
Durable clinical benefit, including 3 of 4 responses ongoing at week 24 / data cutoff (median duration of response not reached)
100% disease control rate, defined as stable disease or better for ≥12 weeks post-infusion
36.4% objective response rate (ORR) across all dose levels (n=11)
Majority had reduction in tumor burden reduction: 83% at RP2D; 73% across all dose levels.
Dr. Chesney commented, "It is very encouraging to see the promising safety and efficacy profile for OBX-115, now observed in the Agni-01 multicenter study. As a highly differentiated, IL2-sparing TIL cell therapy that is compatible with low-dose lymphodepletion, OBX-115 has the potential to transform the treatment landscape and broaden the eligible population for patients with high unmet need."

"The exciting results from OBX-115 in ICI-resistant advanced melanoma further indicate that OBX-115 has promising therapeutic potential, and that ACZ redosing is well-tolerated and has the potential to re-activate and re-expand persistent OBX-115 TIL," commented Parameswaran Hari, M.D., Chief Development Officer of Obsidian. "We look forward to exploring the go-forward melanoma RP2D in Phase 2, and continuing to evaluate OBX-115 in a Phase 1 cohort of patients with advanced non-small cell lung cancer, where we believe the potential impact from an IL2-sparing TIL cell therapy is clinically significant and may expand patient eligibility."

Obsidian is actively enrolling patients with advanced or metastatic melanoma and non-small cell lung cancer (NSCLC) at multiple sites in its ongoing Phase 1/2 Agni-01 multicenter study. Additional details may be found at clinicaltrials.gov, using identifier: NCT06060613.

About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

On June 2, 2025 PanGIA Biotech, a leader in non-invasive cancer diagnostics, reported findings at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) from a prospective, multi-center validation study evaluating its AI-powered, urine-based platform for early-stage prostate cancer detection (Press release, PanGIA Biotech, JUN 2, 2025, View Source [SID1234653653]).

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The study, Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), is the first to clinically validate PanGIA’s novel approach—pairing proprietary chemistry with machine learning to detect cancer-specific biosignatures from a single, non-invasive urine sample.

"This study confirms what we’ve believed from the start: there’s power in non-invasive, data-driven diagnostics," said Holly Magliochetti, CEO of PanGIA Biotech. "Our platform helps clinicians detect prostate cancer when intervention is most effective—without costly or invasive procedures."

Key findings presented included:

Study Cohort: 197 biopsy-confirmed prostate cancer patients and 84 healthy controls.

Classifier Performance: Achieved an F1 score of 0.843 with a recall of 0.967 in distinguishing cancer from non-cancer subjects.

Gleason Score Cohorts: Maintained high recall (>0.89) across Gleason scores 6 through 10, with F1 scores ranging from 0.799 to 0.838.

Non-Invasive Advantage: Demonstrated strong performance in detecting intermediate- and low-grade cancers, offering a less invasive alternative to traditional diagnostics.
Unlike invasive biopsies or blood-based tests that often miss early-stage cases, PanGIA’s approach analyzes urinary biosignatures using proprietary AI models—eliminating the need for sequencing and enabling cost-effective, globally scalable testing.

Previously published in The Analyst, a journal of the Royal Society of Chemistry¹, the PanGIA platform is designed for diverse healthcare environments and holds promise for broad global adoption.

On June 2, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the presentation of new clinical results from the PREDICT DNA and SCANDARE studies highlighting the capabilities of its ultrasensitive NeXT Personal circulating tumor DNA (ctDNA) blood test for monitoring and predicting neoadjuvant therapy (NAT) response in triple negative breast cancer (TNBC), one of the most aggressive types of breast cancer (Press release, Personalis, JUN 2, 2025, View Source [SID1234653652]).

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"Many triple negative breast cancer patients receive neoadjuvant therapy prior to surgery as standard of care. The data from these two studies independently suggest that an ultrasensitive ctDNA assay like NeXT Personal could help these patients better understand their risk of relapse, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "We believe this data, once published, can form the basis for seeking reimbursement coverage for neoadjuvant therapy monitoring in breast cancer. We are excited to continue to work with leading collaborators to expand the data around the use of NeXT Personal in breast cancer with the goal of helping breast cancer patients optimize their care."

Results from the PREDICT DNA study were presented yesterday by Dr. Natasha Hunter, MD, University of Washington, at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting in Chicago in an oral presentation titled "Circulating tumor DNA, pathologic response after neoadjuvant therapy, and survival: First results from TBCRC 040 (the PREDICT DNA trial)."

"The PREDICT DNA study prospectively evaluated ctDNA in early-stage patients with HER2-positive and triple negative breast cancer. The trial was initiated a decade ago and accrued 228 patients across 22 sites in the United States, and was statistically designed and powered for analysis of ctDNA to predict for pathologic complete response (pCR), and whether ctDNA could be a prognostic test to identify patients at high vs. very low risk for recurrence," said Dr. Ben Park, MD PhD, Vanderbilt-Ingram Cancer Center. "We partnered with Personalis because of their technology’s ultrasensitive detection of ctDNA down to 1 to 3 parts per million. Our results demonstrate that patients who ‘clear’ their ctDNA after upfront chemotherapy have excellent outcomes that mirror those with pCR, identifying a group of patients who, despite having residual disease at the time of surgery, will be at extremely low risk for recurrence. Conversely, those with detectable ctDNA after upfront chemotherapy are at a much higher risk of recurrence, and serial ctDNA measurements after surgery can help identify patients who may benefit from either escalation or de-escalation of therapies. We are truly excited by these results as they will allow us to more precisely risk-stratify patients with breast cancer in future trials and clinical practice."

Key findings included:

ctDNA status after completion of NAT (post-NAT) was highly prognostic for relapse-free survival (RFS).
Patients with ctDNA detected post-NAT were ~10 times more likely to relapse than patients who were ctDNA negative.
Detection of ctDNA post-NAT was more predictive of recurrence than pCR.
Patients who did not have detectable post-NAT ctDNA had excellent outcomes regardless of pathologic response.
Preliminary analyses indicate that patients who had post-surgical ctDNA detected were >85 times more likely to experience disease recurrence.
48% of post-NAT ctDNA detections were <100 PPM, highlighting the importance of NeXT Personal’s ultrasensitive performance.
Overall, the results suggest that ultrasensitive ctDNA detection in patients with TNBC after completion of NAT and prior to surgery may be used as a prognostic marker, independent of pCR, to guide clinical decision making for additional adjuvant therapies.
Dr. Luc Cabel, MD, PhD, Institut Curie, Paris, presented results from a second study titled "Ultrasensitive circulating tumor DNA (ctDNA) detection for prognostication in triple-negative breast cancer (TNBC) post-neoadjuvant chemotherapy (NAC)." This study included 86 patients with early stage (Stage I-III) TNBC receiving neoadjuvant therapy. Key findings included:

ctDNA was detected in 100% (84/84) of pretreatment baseline plasma samples.
The majority of ctDNA detections during NAT (51%) and post-NAT (55%) were in the ultrasensitive range below 100 PPM of ctDNA.
Post-NAT ctDNA status was highly prognostic. Patients with ctDNA detected post-NAT were ~36 times more likely to have a distant relapse than patients who tested negative.
For patients who were non-pCR, ctDNA negative patients were 93% less likely to relapse than ctDNA positive patients.
ctDNA status can be combined with pCR status to assess patient distant relapse risk following NAT.
Said François-Clément Bidard, MD, PhD, one of the Institut Curie lead investigators on the study, "Our results uncover the clinical need for ultrasensitive MRD testing, and pave the way for ctDNA-based adjuvant therapy decisions in early triple negative breast cancer."

On June 2, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) reported positive results from the Phase III IMforte study of Tecentriq (atezolizumab) in combination with lurbinectedin (Zepzelca) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (Press release, Genentech, JUN 2, 2025, View Source [SID1234653651]). The data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Safety was consistent with the known safety profiles of Tecentriq and lurbinectedin. These data are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The Lancet.

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"Small cell lung cancer is an aggressive and devastating disease. At the time of diagnosis, the large majority of patients have already progressed to extensive-stage disease and only one out of five survive longer than two years," said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. "The IMforte results are very encouraging showing a potentially practice-changing option that could improve survival for patients with a very high unmet need."

"In the IMforte study, the Tecentriq and lurbinectedin maintenance regimen significantly extended survival for people living with extensive-stage small cell lung cancer," said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. "This study builds on Tecentriq’s well-established safety and efficacy profile as the first immunotherapy for this cancer type and may provide another approach to help physicians and patients better manage this aggressive disease."

Patients in the IMforte study first completed four cycles of Tecentriq combined with chemotherapy, over the course of approximately three months, before being randomized into maintenance treatment. From the point of randomization, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). No new safety signals were observed.

About the IMforte study

IMforte [NCT05091567] is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq (atezolizumab) plus lurbinectedin versus Tecentriq alone as first-line maintenance therapy for adults (≥18 years) with extensive-stage small-cell lung cancer (ES-SCLC). Patients first received induction therapy with Tecentriq, carboplatin and etoposide for four 21-day cycles. Those without disease progression were then randomized 1:1 to receive maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone until disease progression or unacceptable toxicity. The study enrolled 660 patients in the induction phase and randomized 483 patients in the maintenance phase. The study’s primary endpoints were independent review facility (IRF)-assessed progression-free survival (PFS) and overall survival (OS) from randomization into the maintenance phase.

The trial is sponsored by Genentech and co-funded by Jazz Pharmaceuticals.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Important Safety Information and Indications

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called small cell lung cancer (SCLC). Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:

is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown.
It is not known if Tecentriq is safe and effective when used:

In children for the treatment of SCLC.
What is the most important information about Tecentriq?

Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdomen) pain or tenderness
Liver problems

yellowing of your skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in your amount of urine
blood in your urine
swelling of your ankles
loss of appetite
Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in mouth or nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects.

Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.
are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

feeling tired or weak
nausea
hair loss
constipation
diarrhea
decreased appetite
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

You may report side effects to the FDA at 1-800-FDA-1088 or View Source

You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.